PIONEER 12

CompletedPhase 3Results posted

A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

1,441

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04017832

Org study IDNN9924-4309

Secondary ID2018-002589-38European Medicines Agency (EudraCT)

Secondary IDU1111-1188-1256World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-07-12actual

Study start2019-07-29actual

Primary completion2021-10-27actual

Study completion2021-10-27actual

Results first posted2023-09-29actual

Last update posted2024-10-01actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

•Male or female, age above or equal to 18 years at the time of signing informed consent.

For Algeria only: Male or female, age above or equal to 19 years at the time of signing informed consent.

For Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent

•Diagnosed with type 2 diabetes mellitus 60 days or more prior to day of screening.

•HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive).

•Stable daily dose of metformin (equal to or above 1500 mg or maximum tolerated dose as documented in the subject medical record) 60 days or more prior to day of screening

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measure as required by local regulation or practice).

•Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.

•History or presence of pancreatitis (acute or chronic).

•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

•Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation.

•Subjects presently classified as being in New York Heart Association (NYHA) Class IV.

•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.

•Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).

•Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature.

•Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

Endpoints (88)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Other (unclassified)

Patient-reported / QoL

Other clinical outcomes

Renal / kidney

Weight & body composition

14 endpoints

Secondary/registry result

Change From Baseline to Week 26 in Body Weight (Kilogram [kg])

Time frame:From baseline to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram	95% CI
Oral Semaglutide 3 mg	-1.4	—
Oral Semaglutide 7 mg	-2.9	—
Oral Semaglutide 14 mg	-3.8	—
Sitagliptin 100 mg	-0.5	—

Secondary/registry result

Percentage Change From Baseline to Week 26 in Body Weight

Time frame:From baseline to week 26

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Oral Semaglutide 3 mg	-2	—
Oral Semaglutide 7 mg	-4	—
Oral Semaglutide 14 mg	-5	—
Sitagliptin 100 mg	-1	—

Secondary/registry result

Change From Baseline to Week 26 in Body Mass Index (BMI)

Time frame:From baseline to week 26

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per square meter (kg/m^2)	95% CI
Oral Semaglutide 3 mg	-0.5	—
Oral Semaglutide 7 mg	-1.1	—
Oral Semaglutide 14 mg	-1.4	—
Sitagliptin 100 mg	-0.2	—

Secondary/registry result

Change From Baseline to Week 26 in Waist Circumference

Time frame:From baseline to week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter	95% CI
Oral Semaglutide 3 mg	-1.6	—
Oral Semaglutide 7 mg	-2.7	—
Oral Semaglutide 14 mg	-3.7	—
Sitagliptin 100 mg	-0.8	—

Secondary/registry result/low confidence

Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)

Time frame:At week 26

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	109	—
	234	—
Oral Semaglutide 7 mg	175	—
	164	—
Oral Semaglutide 14 mg	199	—
	133	—
Sitagliptin 100 mg	68	—
	282	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)

Time frame:At week 26

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	55	—
	288	—
Oral Semaglutide 7 mg	107	—
	235	—
Oral Semaglutide 14 mg	149	—
	184	—
Sitagliptin 100 mg	28	—
	323	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)

Time frame:At week 26

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	5	—
	338	—
Oral Semaglutide 7 mg	24	—
	318	—
Oral Semaglutide 14 mg	42	—
	291	—
Sitagliptin 100 mg	2	—
	349	—

Secondary/protocol endpoint

Change From Baseline to Week 26 in Body Weight (Kilogram [kg])

Time frame:From baseline to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change From Baseline to Week 26 in Body Weight

Time frame:From baseline to week 26

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 26 in Body Mass Index (BMI)

Time frame:From baseline to week 26

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 26 in Waist Circumference

Time frame:From baseline to week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)

Time frame:At week 26

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)

Time frame:At week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)

Time frame:At week 26

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

20 endpoints

Primary/registry result

Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)

Time frame:From baseline to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage point of HbA1C	95% CI
Oral Semaglutide 3 mgOn-treatment observation period	-0.8	—
In-trial observation period	-0.8	—
Oral Semaglutide 7 mgOn-treatment observation period	-1.3	—
In-trial observation period	-1.3	—
Oral Semaglutide 14 mgOn-treatment observation period	-1.6	—
In-trial observation period	-1.5	—
Sitagliptin 100 mgOn-treatment observation period	-0.7	—
In-trial observation period	-0.7	—

Mean Difference (Net)-0.295% CI-0.3 – -0.1p0.0078Mixed model for repeated measurements

Mean Difference (Net)-0.795% CI-0.8 – -0.6p<0.0001Mixed model for repeated measurements

Mean Difference (Net)-1.095% CI-1.1 – -0.8p< 0.0001Mixed model for repeated measurements

Primary/protocol endpoint

Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)

Time frame:From baseline to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)

Time frame:From baseline to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/l	95% CI
Oral Semaglutide 3 mg	-1.03	—
Oral Semaglutide 7 mg	-1.79	—
Oral Semaglutide 14 mg	-2.00	—
Sitagliptin 100 mg	-0.52	—

Secondary/registry result

Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

Time frame:From baseline to week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Oral Semaglutide 3 mg	-1.5	—
Oral Semaglutide 7 mg	-2.3	—
Oral Semaglutide 14 mg	-2.6	—
Sitagliptin 100 mg	-1.2	—

Secondary/registry result

Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)

Time frame:From baseline to week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Oral Semaglutide 3 mg	-0.4	—
Oral Semaglutide 7 mg	-0.9	—
Oral Semaglutide 14 mg	-1.0	—
Sitagliptin 100 mg	-0.6	—

Secondary/registry result

Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	139	—
	182	—
Oral Semaglutide 7 mg	213	—
	102	—
Oral Semaglutide 14 mg	226	—
	72	—
Sitagliptin 100 mg	122	—
	212	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

Time frame:At week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	81	—
	240	—
Oral Semaglutide 7 mg	161	—
	154	—
Oral Semaglutide 14 mg	188	—
	110	—
Sitagliptin 100 mg	54	—
	280	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)

Time frame:At week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	141	—
	180	—
Oral Semaglutide 7 mg	203	—
	111	—
Oral Semaglutide 14 mg	226	—
	72	—
Sitagliptin 100 mg	129	—
	205	—

Secondary/registry result

Time to Rescue Medication

Time frame:From baseline to week 31

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	5	—
Oral Semaglutide 7 mg	6	—
Oral Semaglutide 14 mg	6	—
Sitagliptin 100 mg	7	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	114	—
	230	—
Oral Semaglutide 7 mg	195	—
	144	—
Oral Semaglutide 14 mg	222	—
	110	—
Sitagliptin 100 mg	79	—
	271	—

Secondary/registry result/low confidence

Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no)

Time frame:At week 26

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	64	—
	280	—
Oral Semaglutide 7 mg	128	—
	211	—
Oral Semaglutide 14 mg	159	—
	173	—
Sitagliptin 100 mg	33	—
	317	—

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)

Time frame:From baseline to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

Time frame:From baseline to week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)

Time frame:From baseline to week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

Time frame:At week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)

Time frame:At week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to Rescue Medication

Time frame:From baseline to week 31

event count, event

Secondary/protocol endpoint

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no)

Time frame:At week 26

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Renal / kidney

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, improvement

Cardiometabolic biomarkers

18 endpoints

Secondary/registry result

Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	0.96	—
Oral Semaglutide 14 mg	0.96	—
Sitagliptin 100 mg	0.99	—

Secondary/registry result

Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Oral Semaglutide 3 mg	1.02	—
Oral Semaglutide 7 mg	0.98	—
Oral Semaglutide 14 mg	0.98	—
Sitagliptin 100 mg	1.01	—

Secondary/registry result

Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

VLDL, change

ratio, improvement

Posted result

Group	Value (mean), Ratio of VLDL cholesterol	95% CI
Oral Semaglutide 3 mg	1.05	—
Oral Semaglutide 7 mg	0.94	—
Oral Semaglutide 14 mg	0.94	—
Sitagliptin 100 mg	0.98	—

Secondary/registry result

Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Oral Semaglutide 3 mg	1.02	—
Oral Semaglutide 7 mg	1.01	—
Oral Semaglutide 14 mg	1.00	—
Sitagliptin 100 mg	1.00	—

Secondary/registry result

Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

Time frame:From baseline to week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Oral Semaglutide 3 mg	0.96	—
Oral Semaglutide 7 mg	0.86	—
Oral Semaglutide 14 mg	0.86	—
Sitagliptin 100 mg	0.91	—

Secondary/registry result

Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)

Time frame:From baseline to week 26

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Oral Semaglutide 3 mg	0.95	—
Oral Semaglutide 7 mg	0.89	—
Oral Semaglutide 14 mg	0.87	—
Sitagliptin 100 mg	0.96	—

Secondary/registry result

Change From Baseline to Week 26 in Vital Signs: Pulse Rate

Time frame:From baseline to week 26

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (beats/min)	95% CI
Oral Semaglutide 3 mg	78	—
Oral Semaglutide 7 mg	78	—
Oral Semaglutide 14 mg	78	—
Sitagliptin 100 mg	78	—

Secondary/registry result

Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure

Time frame:From baseline to week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimeter of mercury (mmHg)	95% CI
Oral Semaglutide 3 mg	131	—
Oral Semaglutide 7 mg	132	—
Oral Semaglutide 14 mg	130	—
Sitagliptin 100 mg	130	—

Secondary/registry result

Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure

Time frame:From baseline to week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), Millimeter of mercury (mmHg)	95% CI
Oral Semaglutide 3 mg	83	—
Oral Semaglutide 7 mg	84	—
Oral Semaglutide 14 mg	83	—
Sitagliptin 100 mg	83	—

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:From baseline to week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

Time frame:From baseline to week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)

Time frame:From baseline to week 26

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline to Week 26 in Vital Signs: Pulse Rate

Time frame:From baseline to week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure

Time frame:From baseline to week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure

Time frame:From baseline to week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

Time frame:From baseline to week 26

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide 3 mgPhysical Function	0.20	—
Role Physical	-0.47	—
Bodily Pain	-0.06	—
General Health	1.47	—
Vitality	0.44	—
Social Function	0.49	—
Role Emotional	0.06	—
Mental Health	0.51	—
Physical Component	0.15	—
Mental Component	0.50	—
Oral Semaglutide 7 mgPhysical Function	0.48	—
Role Physical	-0.41	—
Bodily Pain	-0.37	—
General Health	1.04	—
Vitality	0.84	—
Social Function	-0.36	—
Role Emotional	-0.66	—
Mental Health	0.33	—
Physical Component	0.29	—
Mental Component	-0.07	—
Oral Semaglutide 14 mgPhysical Function	0.93	—
Role Physical	0.28	—
Bodily Pain	0.51	—
General Health	1.95	—
Vitality	1.21	—
Social Function	0.17	—
Role Emotional	0.23	—
Mental Health	0.70	—
Physical Component	0.98	—
Mental Component	0.44	—
Sitagliptin 100 mgPhysical Function	0.31	—
Role Physical	0.24	—
Bodily Pain	0.22	—
General Health	0.95	—
Vitality	0.33	—
Social Function	0.10	—
Role Emotional	0.03	—
Mental Health	-0.7	—
Physical Component	0.69	—
Mental Component	-0.39	—

Secondary/protocol endpoint

Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

Time frame:From baseline to week 26

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

27 endpoints

Secondary/registry result

Number of Treatment-emergent Adverse Events During Exposure to Trial Product

Time frame:From baseline to week 31

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 3 mg	635	—
Oral Semaglutide 7 mg	741	—
Oral Semaglutide 14 mg	793	—
Sitagliptin 100 mg	643	—

Secondary/registry result

Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Time frame:From baseline to week 31

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Oral Semaglutide 3 mg	2	—
Oral Semaglutide 7 mg	2	—
Oral Semaglutide 14 mg	2	—
Sitagliptin 100 mg	1	—

Secondary/registry result

Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils

Time frame:From baseline to week 26

change from baseline, descriptive

Posted result

Group	Value (mean), 10^9 cells per liter	95% CI
Oral Semaglutide 3 mgBasophils	0.01	—
Eosinophils	0.00	—
Lymphocytes	-0.03	—
Monocytes	0.01	—
Neutrophils	0.03	—
Oral Semaglutide 7 mgBasophils	0.01	—
Eosinophils	0.00	—
Lymphocytes	0.01	—
Monocytes	0.01	—
Neutrophils	0.13	—
Oral Semaglutide 14 mgBasophils	0.00	—
Eosinophils	-0.01	—
Lymphocytes	0.00	—
Monocytes	0.01	—
Neutrophils	0.10	—
Sitagliptin 100 mgBasophils	0.00	—
Eosinophils	-0.00	—
Lymphocytes	0.00	—
Monocytes	0.02	—
Neutrophils	0.31	—

Secondary/registry result

Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haematocrit	95% CI
Oral Semaglutide 3 mg	1.01	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Sitagliptin 100 mg	1.00	—

Secondary/registry result

Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haemoglobin	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Sitagliptin 100 mg	1.00	—

Secondary/registry result

Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of leucocytes	95% CI
Oral Semaglutide 3 mg	1.01	—
Oral Semaglutide 7 mg	1.02	—
Oral Semaglutide 14 mg	1.01	—
Sitagliptin 100 mg	1.04	—

Secondary/registry result

Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of thrombocytes	95% CI
Oral Semaglutide 3 mg	0.99	—
Oral Semaglutide 7 mg	0.99	—
Oral Semaglutide 14 mg	0.99	—
Sitagliptin 100 mg	0.97	—

Secondary/registry result

Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcium	95% CI
Oral Semaglutide 3 mg	0.98	—
Oral Semaglutide 7 mg	0.98	—
Oral Semaglutide 14 mg	0.99	—
Sitagliptin 100 mg	0.98	—

Secondary/registry result

Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of potassium	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Sitagliptin 100 mg	1.01	—

Secondary/registry result

Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of urea	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	0.99	—
Oral Semaglutide 14 mg	0.98	—
Sitagliptin 100 mg	1.03	—

Secondary/registry result

Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)

Time frame:From baseline to week 26

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.05	—
Oral Semaglutide 14 mg	1.02	—
Sitagliptin 100 mg	1.01	—

Secondary/registry result

Change From Baseline to Week 26 in Electrocardiogram (ECG) Category

Time frame:From baseline to week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgNormal (Baseline) to normal (week 26)	174	—
Normal (Baseline) to abnormal NCS (week 26)	21	—
Normal (Baseline) to abnormal CS (week 26)	8	—
Abnormal NCS (Baseline) to normal (week 26)	26	—
Abnormal NCS (Baseline) to abnormal NCS (week 26)	56	—
Abnormal NCS (Baseline) to abnormal CS (week 26)	3	—
Abnormal CS (Baseline) to normal (week 26)	8	—
Abnormal CS (Baseline) to abnormal NCS (week 26)	5	—
Abnormal CS (Baseline) to abnormal CS (week 26)	27	—
Oral Semaglutide 7 mgNormal (Baseline) to normal (week 26)	163	—
Normal (Baseline) to abnormal NCS (week 26)	30	—
Normal (Baseline) to abnormal CS (week 26)	3	—
Abnormal NCS (Baseline) to normal (week 26)	27	—
Abnormal NCS (Baseline) to abnormal NCS (week 26)	61	—
Abnormal NCS (Baseline) to abnormal CS (week 26)	3	—
Abnormal CS (Baseline) to normal (week 26)	13	—
Abnormal CS (Baseline) to abnormal NCS (week 26)	3	—
Abnormal CS (Baseline) to abnormal CS (week 26)	25	—
Oral Semaglutide 14 mgNormal (Baseline) to normal (week 26)	165	—
Normal (Baseline) to abnormal NCS (week 26)	29	—
Normal (Baseline) to abnormal CS (week 26)	10	—
Abnormal NCS (Baseline) to normal (week 26)	26	—
Abnormal NCS (Baseline) to abnormal NCS (week 26)	40	—
Abnormal NCS (Baseline) to abnormal CS (week 26)	5	—
Abnormal CS (Baseline) to normal (week 26)	7	—
Abnormal CS (Baseline) to abnormal NCS (week 26)	4	—
Abnormal CS (Baseline) to abnormal CS (week 26)	17	—
Sitagliptin 100 mgNormal (Baseline) to normal (week 26)	175	—
Normal (Baseline) to abnormal NCS (week 26)	17	—
Normal (Baseline) to abnormal CS (week 26)	5	—
Abnormal NCS (Baseline) to normal (week 26)	43	—
Abnormal NCS (Baseline) to abnormal NCS (week 26)	64	—
Abnormal NCS (Baseline) to abnormal CS (week 26)	2	—
Abnormal CS (Baseline) to normal (week 26)	6	—
Abnormal CS (Baseline) to abnormal NCS (week 26)	9	—
Abnormal CS (Baseline) to abnormal CS (week 26)	23	—

Secondary/registry result

Physical Examination Category

Time frame:Baseline and week 26

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgCardiovascular system - Normal (Baseline)	354	—
Cardiovascular system - abnormal NCS (Baseline)	5	—
Cardiovascular system - Abnormal CS (Baseline)	2	—
Cardiovascular system -Normal (Week 26)	319	—
Cardiovascular system - Abnormal NCS (Week 26)	5	—
Cardiovascular system - Abnormal CS (Week 26)	3	—
Central and Peripheral Nervous System - Normal (Baseline)	355	—
Central and Peripheral Nervous System - Abnormal NCS (Baseline)	2	—
Central and Peripheral Nervous System - Abnormal CS (Baseline)	4	—
Central and Peripheral Nervous System - Normal (Week 26)	322	—
Central and Peripheral Nervous System - Abnormal NCS (Week 26)	2	—
Central and Peripheral Nervous System - Abnormal CS (Week 26)	2	—
Gastrointestinal System incl. Mouth - Normal (Baseline)	350	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline)	10	—
Gastrointestinal System incl. Mouth - Abnormal CS (Baseline)	1	—
Gastrointestinal System incl. Mouth - Normal (Week 26)	314	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26)	12	—
Gastrointestinal System incl. Mouth - Abnormal CS (Week 26)	0	—
General Appearance - Normal (Baseline)	329	—
General Appearance - Abnormal NCS (Baseline)	25	—
General Appearance - Abnormal CS (Baseline)	7	—
General Appearance - Normal (Week 26)	300	—
General Appearance - Abnormal NCS (Week 26)	21	—
General Appearance - Abnormal CS (Week 26)	6	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline)	348	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline)	9	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline)	4	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26)	322	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26)	3	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26)	2	—
Lymph Node Palpation - Normal (Baseline)	361	—
Lymph Node Palpation - Abnormal NCS (Baseline)	0	—
Lymph Node Palpation - Abnormal CS (Baseline)	0	—
Lymph Node Palpation - Normal (Week 26)	325	—
Lymph Node Palpation - Abnormal NCS (Week 26)	1	—
Lymph Node Palpation - Abnormal CS (Week 26)	0	—
Musculoskeletal System - Normal (Baseline)	344	—
Musculoskeletal System - Abnormal NCS (Baseline)	13	—
Musculoskeletal System - Abnormal CS (Baseline)	4	—
Musculoskeletal System - Normal (Week 26)	314	—
Musculoskeletal System - Abnormal NCS (Week 26)	6	—
Musculoskeletal System - Abnormal CS (Week 26)	6	—
Respiratory System - Normal (Baseline)	355	—
Respiratory System -Abnormal NCS (Baseline)	3	—
Respiratory System - Abnormal CS (Baseline)	3	—
Respiratory System - Normal (Week 26)	324	—
Respiratory System - Abnormal NCS (Week 26)	2	—
Respiratory System - Abnormal CS (Week 26)	0	—
Skin - Normal (Baseline)	282	—
Skin - Abnormal NCS (Baseline)	71	—
Skin - Abnormal CS (Baseline)	8	—
Skin - Normal (Week 26)	260	—
Skin - Abnormal NCS (Week 26)	60	—
Skin - Abnormal CS (Week 26)	7	—
Thyroid Gland - Normal (Baseline)	356	—
Thyroid Gland - Abnormal NCS (Baseline)	4	—
Thyroid Gland - Abnormal CS (Baseline)	1	—
Thyroid Gland - Normal (Week 26)	322	—
Thyroid Gland - Abnormal NCS (Week 26)	3	—
Thyroid Gland - Abnormal CS (Week 26)	2	—
Oral Semaglutide 7 mgCardiovascular system - Normal (Baseline)	353	—
Cardiovascular system - abnormal NCS (Baseline)	4	—
Cardiovascular system - Abnormal CS (Baseline)	1	—
Cardiovascular system -Normal (Week 26)	322	—
Cardiovascular system - Abnormal NCS (Week 26)	2	—
Cardiovascular system - Abnormal CS (Week 26)	2	—
Central and Peripheral Nervous System - Normal (Baseline)	351	—
Central and Peripheral Nervous System - Abnormal NCS (Baseline)	5	—
Central and Peripheral Nervous System - Abnormal CS (Baseline)	2	—
Central and Peripheral Nervous System - Normal (Week 26)	321	—
Central and Peripheral Nervous System - Abnormal NCS (Week 26)	3	—
Central and Peripheral Nervous System - Abnormal CS (Week 26)	2	—
Gastrointestinal System incl. Mouth - Normal (Baseline)	343	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline)	14	—
Gastrointestinal System incl. Mouth - Abnormal CS (Baseline)	1	—
Gastrointestinal System incl. Mouth - Normal (Week 26)	315	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26)	10	—
Gastrointestinal System incl. Mouth - Abnormal CS (Week 26)	1	—
General Appearance - Normal (Baseline)	325	—
General Appearance - Abnormal NCS (Baseline)	27	—
General Appearance - Abnormal CS (Baseline)	6	—
General Appearance - Normal (Week 26)	295	—
General Appearance - Abnormal NCS (Week 26)	27	—
General Appearance - Abnormal CS (Week 26)	4	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline)	349	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline)	8	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26)	319	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26)	5	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26)	1	—
Lymph Node Palpation - Normal (Baseline)	353	—
Lymph Node Palpation - Abnormal NCS (Baseline)	5	—
Lymph Node Palpation - Abnormal CS (Baseline)	0	—
Lymph Node Palpation - Normal (Week 26)	323	—
Lymph Node Palpation - Abnormal NCS (Week 26)	3	—
Lymph Node Palpation - Abnormal CS (Week 26)	0	—
Musculoskeletal System - Normal (Baseline)	345	—
Musculoskeletal System - Abnormal NCS (Baseline)	8	—
Musculoskeletal System - Abnormal CS (Baseline)	5	—
Musculoskeletal System - Normal (Week 26)	319	—
Musculoskeletal System - Abnormal NCS (Week 26)	4	—
Musculoskeletal System - Abnormal CS (Week 26)	3	—
Respiratory System - Normal (Baseline)	355	—
Respiratory System -Abnormal NCS (Baseline)	3	—
Respiratory System - Abnormal CS (Baseline)	0	—
Respiratory System - Normal (Week 26)	325	—
Respiratory System - Abnormal NCS (Week 26)	1	—
Respiratory System - Abnormal CS (Week 26)	0	—
Skin - Normal (Baseline)	282	—
Skin - Abnormal NCS (Baseline)	65	—
Skin - Abnormal CS (Baseline)	11	—
Skin - Normal (Week 26)	263	—
Skin - Abnormal NCS (Week 26)	52	—
Skin - Abnormal CS (Week 26)	11	—
Thyroid Gland - Normal (Baseline)	351	—
Thyroid Gland - Abnormal NCS (Baseline)	4	—
Thyroid Gland - Abnormal CS (Baseline)	3	—
Thyroid Gland - Normal (Week 26)	319	—
Thyroid Gland - Abnormal NCS (Week 26)	4	—
Thyroid Gland - Abnormal CS (Week 26)	3	—
Oral Semaglutide 14 mgCardiovascular system - Normal (Baseline)	355	—
Cardiovascular system - abnormal NCS (Baseline)	6	—
Cardiovascular system - Abnormal CS (Baseline)	0	—
Cardiovascular system -Normal (Week 26)	301	—
Cardiovascular system - Abnormal NCS (Week 26)	3	—
Cardiovascular system - Abnormal CS (Week 26)	1	—
Central and Peripheral Nervous System - Normal (Baseline)	358	—
Central and Peripheral Nervous System - Abnormal NCS (Baseline)	3	—
Central and Peripheral Nervous System - Abnormal CS (Baseline)	0	—
Central and Peripheral Nervous System - Normal (Week 26)	302	—
Central and Peripheral Nervous System - Abnormal NCS (Week 26)	2	—
Central and Peripheral Nervous System - Abnormal CS (Week 26)	1	—
Gastrointestinal System incl. Mouth - Normal (Baseline)	353	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline)	7	—
Gastrointestinal System incl. Mouth - Abnormal CS (Baseline)	1	—
Gastrointestinal System incl. Mouth - Normal (Week 26)	300	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26)	4	—
Gastrointestinal System incl. Mouth - Abnormal CS (Week 26)	1	—
General Appearance - Normal (Baseline)	328	—
General Appearance - Abnormal NCS (Baseline)	21	—
General Appearance - Abnormal CS (Baseline)	12	—
General Appearance - Normal (Week 26)	280	—
General Appearance - Abnormal NCS (Week 26)	19	—
General Appearance - Abnormal CS (Week 26)	6	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline)	351	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline)	5	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline)	4	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26)	297	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26)	4	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26)	2	—
Lymph Node Palpation - Normal (Baseline)	357	—
Lymph Node Palpation - Abnormal NCS (Baseline)	3	—
Lymph Node Palpation - Abnormal CS (Baseline)	1	—
Lymph Node Palpation - Normal (Week 26)	304	—
Lymph Node Palpation - Abnormal NCS (Week 26)	1	—
Lymph Node Palpation - Abnormal CS (Week 26)	0	—
Musculoskeletal System - Normal (Baseline)	351	—
Musculoskeletal System - Abnormal NCS (Baseline)	7	—
Musculoskeletal System - Abnormal CS (Baseline)	3	—
Musculoskeletal System - Normal (Week 26)	301	—
Musculoskeletal System - Abnormal NCS (Week 26)	2	—
Musculoskeletal System - Abnormal CS (Week 26)	2	—
Respiratory System - Normal (Baseline)	359	—
Respiratory System -Abnormal NCS (Baseline)	1	—
Respiratory System - Abnormal CS (Baseline)	1	—
Respiratory System - Normal (Week 26)	305	—
Respiratory System - Abnormal NCS (Week 26)	0	—
Respiratory System - Abnormal CS (Week 26)	0	—
Skin - Normal (Baseline)	296	—
Skin - Abnormal NCS (Baseline)	54	—
Skin - Abnormal CS (Baseline)	11	—
Skin - Normal (Week 26)	256	—
Skin - Abnormal NCS (Week 26)	42	—
Skin - Abnormal CS (Week 26)	7	—
Thyroid Gland - Normal (Baseline)	358	—
Thyroid Gland - Abnormal NCS (Baseline)	1	—
Thyroid Gland - Abnormal CS (Baseline)	2	—
Thyroid Gland - Normal (Week 26)	304	—
Thyroid Gland - Abnormal NCS (Week 26)	0	—
Thyroid Gland - Abnormal CS (Week 26)	1	—
Sitagliptin 100 mgCardiovascular system - Normal (Baseline)	356	—
Cardiovascular system - abnormal NCS (Baseline)	2	—
Cardiovascular system - Abnormal CS (Baseline)	0	—
Cardiovascular system -Normal (Week 26)	339	—
Cardiovascular system - Abnormal NCS (Week 26)	2	—
Cardiovascular system - Abnormal CS (Week 26)	0	—
Central and Peripheral Nervous System - Normal (Baseline)	357	—
Central and Peripheral Nervous System - Abnormal NCS (Baseline)	1	—
Central and Peripheral Nervous System - Abnormal CS (Baseline)	0	—
Central and Peripheral Nervous System - Normal (Week 26)	339	—
Central and Peripheral Nervous System - Abnormal NCS (Week 26)	2	—
Central and Peripheral Nervous System - Abnormal CS (Week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (Baseline)	346	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline)	11	—
Gastrointestinal System incl. Mouth - Abnormal CS (Baseline)	1	—
Gastrointestinal System incl. Mouth - Normal (Week 26)	329	—
Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26)	10	—
Gastrointestinal System incl. Mouth - Abnormal CS (Week 26)	2	—
General Appearance - Normal (Baseline)	328	—
General Appearance - Abnormal NCS (Baseline)	22	—
General Appearance - Abnormal CS (Baseline)	8	—
General Appearance - Normal (Week 26)	313	—
General Appearance - Abnormal NCS (Week 26)	21	—
General Appearance - Abnormal CS (Week 26)	7	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline)	344	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline)	6	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline)	5	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26)	330	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26)	4	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26)	5	—
Lymph Node Palpation - Normal (Baseline)	357	—
Lymph Node Palpation - Abnormal NCS (Baseline)	1	—
Lymph Node Palpation - Abnormal CS (Baseline)	0	—
Lymph Node Palpation - Normal (Week 26)	341	—
Lymph Node Palpation - Abnormal NCS (Week 26)	0	—
Lymph Node Palpation - Abnormal CS (Week 26)	0	—
Musculoskeletal System - Normal (Baseline)	352	—
Musculoskeletal System - Abnormal NCS (Baseline)	4	—
Musculoskeletal System - Abnormal CS (Baseline)	2	—
Musculoskeletal System - Normal (Week 26)	335	—
Musculoskeletal System - Abnormal NCS (Week 26)	3	—
Musculoskeletal System - Abnormal CS (Week 26)	3	—
Respiratory System - Normal (Baseline)	357	—
Respiratory System -Abnormal NCS (Baseline)	1	—
Respiratory System - Abnormal CS (Baseline)	0	—
Respiratory System - Normal (Week 26)	341	—
Respiratory System - Abnormal NCS (Week 26)	0	—
Respiratory System - Abnormal CS (Week 26)	0	—
Skin - Normal (Baseline)	277	—
Skin - Abnormal NCS (Baseline)	65	—
Skin - Abnormal CS (Baseline)	16	—
Skin - Normal (Week 26)	267	—
Skin - Abnormal NCS (Week 26)	60	—
Skin - Abnormal CS (Week 26)	14	—
Thyroid Gland - Normal (Baseline)	350	—
Thyroid Gland - Abnormal NCS (Baseline)	4	—
Thyroid Gland - Abnormal CS (Baseline)	4	—
Thyroid Gland - Normal (Week 26)	337	—
Thyroid Gland - Abnormal NCS (Week 26)	2	—
Thyroid Gland - Abnormal CS (Week 26)	2	—

Secondary/registry result

Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Time frame:From baseline to week 31

Severe hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	2	—
Oral Semaglutide 7 mg	2	—
Oral Semaglutide 14 mg	2	—
Sitagliptin 100 mg	1	—

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events During Exposure to Trial Product

Time frame:From baseline to week 31

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Time frame:From baseline to week 31

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils

Time frame:From baseline to week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)

Time frame:From baseline to week 26

Thyroid event

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline to Week 26 in Electrocardiogram (ECG) Category

Time frame:From baseline to week 26

categorical status, descriptive

Secondary/protocol endpoint

Physical Examination Category

Time frame:Baseline and week 26

categorical status, descriptive

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Time frame:From baseline to week 31

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Other clinical outcomes

2 endpoints

Secondary/registry result

Change From Baseline to Week 26 in Eye Examination Category

Time frame:From baseline to week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgLeft Eye Ophthalmoscopy - Normal (Baseline)	245	—
Left Eye Ophthalmoscopy - Abnormal NCS (Baseline)	60	—
Left Eye Ophthalmoscopy - Abnormal CS (Baseline)	56	—
Left Eye Ophthalmoscopy - Normal (Week 26)	221	—
Left Eye Ophthalmoscopy -Abnormal NCS (Week 26)	49	—
Left Eye Ophthalmoscopy - Abnormal CS (Week 26)	55	—
Right Eye Ophthalmoscopy - Normal (Baseline)	240	—
Right Eye Ophthalmoscopy - Abnormal NCS (Baseline)	64	—
Right Eye Ophthalmoscopy - Abnormal CS (Baseline)	57	—
Right Eye Ophthalmoscopy - Normal (Week 26)	223	—
Right Eye Ophthalmoscopy - Abnormal NCS (Week 26)	49	—
Right Eye Ophthalmoscopy - Abnormal CS (Week 26)	53	—
Oral Semaglutide 7 mgLeft Eye Ophthalmoscopy - Normal (Baseline)	240	—
Left Eye Ophthalmoscopy - Abnormal NCS (Baseline)	51	—
Left Eye Ophthalmoscopy - Abnormal CS (Baseline)	67	—
Left Eye Ophthalmoscopy - Normal (Week 26)	226	—
Left Eye Ophthalmoscopy -Abnormal NCS (Week 26)	44	—
Left Eye Ophthalmoscopy - Abnormal CS (Week 26)	53	—
Right Eye Ophthalmoscopy - Normal (Baseline)	234	—
Right Eye Ophthalmoscopy - Abnormal NCS (Baseline)	54	—
Right Eye Ophthalmoscopy - Abnormal CS (Baseline)	69	—
Right Eye Ophthalmoscopy - Normal (Week 26)	218	—
Right Eye Ophthalmoscopy - Abnormal NCS (Week 26)	49	—
Right Eye Ophthalmoscopy - Abnormal CS (Week 26)	55	—
Oral Semaglutide 14 mgLeft Eye Ophthalmoscopy - Normal (Baseline)	254	—
Left Eye Ophthalmoscopy - Abnormal NCS (Baseline)	61	—
Left Eye Ophthalmoscopy - Abnormal CS (Baseline)	46	—
Left Eye Ophthalmoscopy - Normal (Week 26)	217	—
Left Eye Ophthalmoscopy -Abnormal NCS (Week 26)	50	—
Left Eye Ophthalmoscopy - Abnormal CS (Week 26)	34	—
Right Eye Ophthalmoscopy - Normal (Baseline)	257	—
Right Eye Ophthalmoscopy - Abnormal NCS (Baseline)	56	—
Right Eye Ophthalmoscopy - Abnormal CS (Baseline)	48	—
Right Eye Ophthalmoscopy - Normal (Week 26)	220	—
Right Eye Ophthalmoscopy - Abnormal NCS (Week 26)	45	—
Right Eye Ophthalmoscopy - Abnormal CS (Week 26)	36	—
Sitagliptin 100 mgLeft Eye Ophthalmoscopy - Normal (Baseline)	248	—
Left Eye Ophthalmoscopy - Abnormal NCS (Baseline)	52	—
Left Eye Ophthalmoscopy - Abnormal CS (Baseline)	58	—
Left Eye Ophthalmoscopy - Normal (Week 26)	240	—
Left Eye Ophthalmoscopy -Abnormal NCS (Week 26)	39	—
Left Eye Ophthalmoscopy - Abnormal CS (Week 26)	56	—
Right Eye Ophthalmoscopy - Normal (Baseline)	240	—
Right Eye Ophthalmoscopy - Abnormal NCS (Baseline)	53	—
Right Eye Ophthalmoscopy - Abnormal CS (Baseline)	65	—
Right Eye Ophthalmoscopy - Normal (Week 26)	233	—
Right Eye Ophthalmoscopy - Abnormal NCS (Week 26)	43	—
Right Eye Ophthalmoscopy - Abnormal CS (Week 26)	59	—

Secondary/protocol endpoint

Change From Baseline to Week 26 in Eye Examination Category

Time frame:From baseline to week 26

categorical status, descriptive

Other (unclassified)

4 endpoints

Secondary/registry result/low confidence

Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of sodium	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Sitagliptin 100 mg	1.00	—

Secondary/registry result/low confidence

Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of albumin	95% CI
Oral Semaglutide 3 mg	0.99	—
Oral Semaglutide 7 mg	0.99	—
Oral Semaglutide 14 mg	0.99	—
Sitagliptin 100 mg	0.99	—

Secondary/protocol endpoint

Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)

Time frame:From baseline to week 26

ratio, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes uncontrolled with metformin: PIONEER 12, a double-blind, Phase IIIa, randomised trial.
Diabetologia2024 Sep (month)PMID38985161doi:10.1007/s00125-024-06133-4via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.