PIONEER 7

CompletedPhase 3Results posted

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

504

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-9.5%

Primary endpoint

•HbA1c <7.0% achievement

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 IDNCT02849080

Org study IDNN9924-4257

Secondary ID2015-005593-38

Secondary IDU1111-1177-5103WHO

Timeline

Milestones

Study first posted2016-07-29estimated

Study start2016-09-20actual

Primary completion2018-02-28actual

Study completion2019-03-27actual

Results first posted2020-02-17actual

Last update posted2022-07-20actual

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

Main phase (the inclusion criteria for the main phase are not reassessed for the extension phase):

•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 Korea only: Male or female, age above or equal to 19 years at the time of signing informed consent

•Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening

•HbA1c (glycosylated haemoglobin) 7.5-9.5% (58-80 mmol/mol) (both inclusive)

•Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator

•Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening:

•Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record)

•Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)

•Sodium glucose co-transporter 2 inhibitors

•Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)

Extension phase:

•Informed consent for the extension phase obtained before any trial-related activities for the extension phase.

•On randomised treatment with or without rescue medication at week 52.

Exclusion criteria

Main phase (the exclusion criteria for the main phase are not reassessed for the extension phase):

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply

•Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

•Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma

•History 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 or hospitalisation 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 Class IV

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

•Subjects with alanine aminotransferase above 2.5 x upper normal limit

•Renal impairment defined as Estimated Glomerular Filtration rate 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days

•Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation

•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

•History of diabetic ketoacidosis

Extension phase: There are no new exclusion criteria for the extension phase

Endpoints (138)

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

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

32 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (Kg)	95% CI
Oral Semaglutide Flex- Main PhaseIn-trial	-2.7	—
On-treatment without rescue medication	-2.9	—
Sitagliptin 100 mg- Main PhaseIn-trial	-0.7	—
On-treatment without rescue medication	-0.9	—

Treatment difference-1.995% CI-2.6 – -1.2p<0.0001Pattern mixture model

Treatment difference-2.295% CI-2.9 – -1.5p<0.0001Mixed model for repeated measurements

Secondary/registry result

Change in Body Weight (%)

Time frame:Week 0, week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Oral Semaglutide Flex- Main Phase	-2.99	—
Sitagliptin 100 mg- Main Phase	-0.76	—

Secondary/registry result

Change in BMI

Time frame:Week 0, Week 52

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms per square meter (kg/m^2)	95% CI
Oral Semaglutide Flex- Main Phase	-1.0	—
Sitagliptin 100 mg- Main Phase	-0.3	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeters (cm)	95% CI
Oral Semaglutide Flex- Main Phase	-2.6	—
Sitagliptin 100 mg- Main Phase	-0.7	—

Secondary/registry result

Participants Who Achieve Weight Loss ≥5% (Yes/no)

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main PhaseYes	63	—
No	170	—
Sitagliptin 100 mg- Main PhaseYes	29	—
No	210	—

Secondary/registry result

Participants Who Achieve Weight Loss ≥10% (Yes/no)

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main PhaseYes	15	—
No	218	—
Sitagliptin 100 mg- Main PhaseYes	5	—
No	234	—

Secondary/registry result

Change in Body Weight- Switch

Time frame:Week 52, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Oral Semaglutide Flex- Switch	-2.6	—
Sitagliptin 100 mg- Switch	-0.9	—

Secondary/registry result

Change in Body Weight (%)- Switch

Time frame:Week 52, week 104

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Oral Semaglutide Flex- Switch	-3.12	—
Sitagliptin 100 mg- Switch	-0.70	—

Secondary/registry result

Change in BMI- Switch

Time frame:Week 52, Week 104

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Oral Semaglutide Flex- Switch	-0.9	—
Sitagliptin 100 mg- Switch	-0.3	—

Secondary/registry result

Change in Waist Circumference- Switch

Time frame:Week 52, week 104

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeters (cm)	95% CI
Oral Semaglutide Flex- Switch	-1.8	—
Sitagliptin 100 mg- Switch	-0.9	—

Secondary/registry result

Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	31	—
	62	—
Sitagliptin 100 mg- Switch	12	—
	85	—

Secondary/registry result

Change in Body Weight (kg)- Sustainability

Time frame:Week 0, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Oral Semaglutide Flex- Sustainability	-3.7	—

Secondary/registry result

Change in Body Weight (%)- Sustainability

Time frame:Week 0, week 104

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Oral Semaglutide Flex- Sustainability	-4.03	—

Secondary/registry result

Change in BMI- Sustainability

Time frame:Week 0, Week 104

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Oral Semaglutide Flex- Sustainability	-1.3	—

Secondary/registry result

Change in Waist Circumference- Sustainability

Time frame:Week 0, week 104

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Oral Semaglutide Flex- Sustainability	-2.5	—

Secondary/registry result

Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability

Time frame:Week 104

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Sustainability	61	—
	119	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)

Time frame:Week 0, week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:Week 0, Week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve Weight Loss ≥5% (Yes/no)

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieve Weight Loss ≥10% (Yes/no)

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight- Switch

Time frame:Week 52, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)- Switch

Time frame:Week 52, week 104

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI- Switch

Time frame:Week 52, Week 104

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference- Switch

Time frame:Week 52, week 104

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight (kg)- Sustainability

Time frame:Week 0, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)- Sustainability

Time frame:Week 0, week 104

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI- Sustainability

Time frame:Week 0, Week 104

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference- Sustainability

Time frame:Week 0, week 104

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability

Time frame:Week 104

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

44 endpoints

Primary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main PhaseIn-trial	134	—
In-trial	96	—
On-treatment without rescue medication	123	—
On-treatment without rescue medication	73	—
Sitagliptin 100 mg- Main PhaseIn-trial	60	—
In-trial	178	—
On-treatment without rescue medication	52	—
On-treatment without rescue medication	132	—

Odds Ratio (OR)4.4095% CI2.89 – 6.70p<0.0001Pattern mixture model

Odds Ratio (OR)5.5495% CI3.54 – 8.68p<0.0001Regression, Logistic

Primary/protocol endpoint

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/registry result

Change in HbA1c

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide Flex- Main Phase	-1.3	—
Sitagliptin 100 mg- Main Phase	-0.8	—

Secondary/registry result

Change in FPG

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Oral Semaglutide Flex- Main Phase	-2.41	—
Sitagliptin 100 mg- Main Phase	-1.39	—

Secondary/registry result

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main PhaseYes	76	—
No	154	—
Sitagliptin 100 mg- Main PhaseYes	29	—
No	209	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main PhaseYes	104	—
No	126	—
Sitagliptin 100 mg- Main PhaseYes	35	—
No	203	—

Secondary/registry result

Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)

Time frame:Week 52

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main PhaseYes	80	—
No	150	—
Sitagliptin 100 mg- Main PhaseYes	25	—
No	213	—

Secondary/registry result

Time to Rescue Medication

Time frame:Weeks 0-52

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main Phase	8	—
Sitagliptin 100 mg- Main Phase	40	—

Hazard Ratio (HR)0.1895% CI0.09 – 0.39p<0.0001Regression, Cox

Secondary/registry result/low confidence

Time to Additional Anti-diabetic Medication

Time frame:Weeks 0-52

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main Phase	22	—
Sitagliptin 100 mg- Main Phase	47	—

Hazard Ratio (HR)0.5895% CI0.37 – 0.91p0.0175Regression, Cox

Secondary/registry result

Change in HbA1c- Switch

Time frame:Week 52, week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide Flex- Switch	-0.2	—
Sitagliptin 100 mg- Switch	0.0	—

Secondary/registry result

Change in FPG- Switch

Time frame:Week 52, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Oral Semaglutide Flex- Switch	-0.35	—
Sitagliptin 100 mg- Switch	0.02	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	44	—
	48	—
Sitagliptin 100 mg- Switch	26	—
	70	—

Secondary/registry result

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	28	—
	64	—
Sitagliptin 100 mg- Switch	11	—
	85	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	36	—
	56	—
Sitagliptin 100 mg- Switch	18	—
	78	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	41	—
Sitagliptin 100 mg- Switch	23	—

Secondary/registry result

Time to Additional Anti-diabetic Medication- Switch

Time frame:Weeks 53-104

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	15	—
Sitagliptin 100 mg- Switch	26	—

Hazard Ratio (HR)0.7795% CI0.39 – 1.50p0.4381Regression, Cox

Secondary/registry result

Time to Rescue Medication- Switch

Time frame:Weeks 53-104

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	9	—
Sitagliptin 100 mg- Switch	23	—

Hazard Ratio (HR)0.4795% CI0.20 – 1.09p0.0790Regression, Cox

Secondary/registry result

Change in HbA1c- Sustainability

Time frame:Week 0, week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide Flex- Sustainability	-1.3	—

Secondary/registry result

Change in FPG- Sustainability

Time frame:Week 0, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Oral Semaglutide Flex- Sustainability	-39.4	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Sustainability	101	—
	79	—

Secondary/registry result

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Sustainability	63	—
	117	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Sustainability	73	—
	107	—

Secondary/registry result

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c, change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Sustainability	126	—
	54	—

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)

Time frame:Week 52

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

Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)

Time frame:Week 52

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Secondary/protocol endpoint

Time to Rescue Medication

Time frame:Weeks 0-52

time to event, event

Secondary/protocol endpoint

Time to Additional Anti-diabetic Medication

Time frame:Weeks 0-52

time to event, event

Secondary/protocol endpoint

Change in HbA1c- Switch

Time frame:Week 52, week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG- Switch

Time frame:Week 52, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch

Time frame:Week 104 (i.e., after 52 weeks of treatment in the extension phase)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to Additional Anti-diabetic Medication- Switch

Time frame:Weeks 53-104

event count, event

Secondary/protocol endpoint

Time to Rescue Medication- Switch

Time frame:Weeks 53-104

event count, event

Secondary/protocol endpoint

Change in HbA1c- Sustainability

Time frame:Week 0, week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG- Sustainability

Time frame:Week 0, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability

Time frame:Week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability

Time frame:Week 104

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c, change

Cardiometabolic biomarkers

20 endpoints

Secondary/registry result

Change in Total Cholesterol (Ratio to Baseline)

Time frame:Week 0, Week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Oral Semaglutide Flex- Main Phase	0.96	—
Sitagliptin 100 mg- Main Phase	1.01	—

Secondary/registry result

Change in LDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Oral Semaglutide Flex- Main Phase	0.97	—
Sitagliptin 100 mg- Main Phase	1.03	—

Secondary/registry result

Change in HDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Oral Semaglutide Flex- Main Phase	1.00	—
Sitagliptin 100 mg- Main Phase	1.02	—

Secondary/registry result

Change in Triglycerides (Ratio to Baseline)

Time frame:Week 0, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Oral Semaglutide Flex- Main Phase	0.89	—
Sitagliptin 100 mg- Main Phase	0.91	—

Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Oral Semaglutide Flex- Main Phase	3	—
Sitagliptin 100 mg- Main Phase	0	—

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Oral Semaglutide Flex- Main PhaseSystolic blood pressure	-3	—
Diastolic blood pressure	-0	—
Sitagliptin 100 mg- Main PhaseSystolic blood pressure	-2	—
Diastolic blood pressure	-1	—

Secondary/registry result

Change in Pulse Rate- Switch

Time frame:Week 52, week 104

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Oral Semaglutide Flex- Switch	1	—
Sitagliptin 100 mg- Switch	-0	—

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch

Time frame:Week 52, week 104

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Oral Semaglutide Flex- SwitchSystolic blood pressure	-3	—
Diastolic blood pressure	-1	—
Sitagliptin 100 mg- SwitchSystolic blood pressure	2	—
Diastolic blood pressure	-0	—

Secondary/registry result

Change in Pulse Rate- Sustainability

Time frame:Week 0, week 104

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Oral Semaglutide Flex- Sustainability	2	—

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability

Time frame:Week 0, week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Oral Semaglutide Flex- SustainabilitySystolic blood pressure	-3	—
Diastolic blood pressure	-1	—

Secondary/protocol endpoint

Change in Total Cholesterol (Ratio to Baseline)

Time frame:Week 0, Week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in LDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in HDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Triglycerides (Ratio to Baseline)

Time frame:Week 0, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Pulse Rate- Switch

Time frame:Week 52, week 104

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch

Time frame:Week 52, week 104

change from baseline, improvement

Secondary/protocol endpoint

Change in Pulse Rate- Sustainability

Time frame:Week 0, week 104

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability

Time frame:Week 0, week 104

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Patient-reported / QoL

12 endpoints

Secondary/registry result

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Time frame:Week 0, week 52

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide Flex- Main PhasePhysical functioning	1.54	—
Role physical	0.40	—
Bodily pain	1.09	—
General health	1.83	—
Vitality	1.07	—
Social functioning	0.38	—
Role emotional	-0.91	—
Mental health	1.21	—
PCS	1.51	—
MCS	0.01	—
Sitagliptin 100 mg- Main PhasePhysical functioning	-0.03	—
Role physical	0.13	—
Bodily pain	1.20	—
General health	1.62	—
Vitality	0.51	—
Social functioning	0.41	—
Role emotional	-0.54	—
Mental health	0.86	—
PCS	0.74	—
MCS	0.26	—

Secondary/registry result

Change in DTSQ

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide Flex- Main Phase1) Satisfaction with treatment	1.09	—
2) Feeling of unacceptably high blood sugars	-1.58	—
3) Feeling of unacceptably low blood sugars	-0.15	—
4) Convenience of treatment	0.82	—
5) Flexibility of current treatment	0.80	—
6) Satisfaction with understanding of diabetes	0.77	—
7) Recommending treatment to others	0.88	—
8) Satisfaction to continue with present treatment	1.03	—
Total treatment satisfaction score	5.39	—
Sitagliptin 100 mg- Main Phase1) Satisfaction with treatment	0.92	—
2) Feeling of unacceptably high blood sugars	-1.14	—
3) Feeling of unacceptably low blood sugars	-0.24	—
4) Convenience of treatment	0.59	—
5) Flexibility of current treatment	0.68	—
6) Satisfaction with understanding of diabetes	0.77	—
7) Recommending treatment to others	0.79	—
8) Satisfaction to continue with present treatment	0.95	—
Total treatment satisfaction score	4.70	—

Secondary/registry result

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch

Time frame:Week 52, week 104

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide Flex- SwitchPhysical functioning	1.14	—
Role physical	1.37	—
Bodily pain	-0.18	—
General health	0.69	—
Vitality	-0.18	—
Social functioning	0.21	—
Role emotional	1.72	—
Mental health	0.37	—
PCS	0.66	—
MCS	0.52	—
Sitagliptin 100 mg- SwitchPhysical functioning	-0.97	—
Role physical	-0.22	—
Bodily pain	-0.30	—
General health	0.53	—
Vitality	-0.15	—
Social functioning	0.10	—
Role emotional	-0.39	—
Mental health	0.20	—
PCS	-0.43	—
MCS	0.19	—

Secondary/registry result

Change in DTSQ- Switch

Time frame:Week 52, week 104

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide Flex- Switch1) Satisfaction with treatment	0.06	—
2) Feeling of unacceptably high blood sugars	-0.32	—
3) Feeling of unacceptably low blood sugars	0.02	—
4) Convenience of treatment	0.13	—
5) Flexibility of current treatment	0.01	—
6) Satisfaction with understanding of diabetes	0.02	—
7) Recommending treatment to others	0.04	—
8) Satisfaction to continue with present treatment	-0.05	—
Total treatment satisfaction score	0.20	—
Sitagliptin 100 mg- Switch1) Satisfaction with treatment	-0.24	—
2) Feeling of unacceptably high blood sugars	0.09	—
3) Feeling of unacceptably low blood sugars	0.23	—
4) Convenience of treatment	0.13	—
5) Flexibility of current treatment	0.06	—
6) Satisfaction with understanding of diabetes	0.04	—
7) Recommending treatment to others	-0.05	—
8) Satisfaction to continue with present treatment	0.00	—
Total treatment satisfaction score	-0.06	—

Secondary/registry result

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability

Time frame:Week 0, week 104

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide Flex- SustainabilityPhysical functioning	1.44	—
Role physical	0.22	—
Bodily pain	1.07	—
General health	1.98	—
Vitality	0.97	—
Social functioning	-0.11	—
Role emotional	-0.04	—
Mental health	1.05	—
PCS	1.33	—
MCS	0.20	—

Secondary/registry result

Change in DTSQ- Sustainability

Time frame:Week 0, week 104

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide Flex- Sustainability1) Satisfaction with treatment	1.19	—
2) Feeling of unacceptably high blood sugars	-1.46	—
3) Feeling of unacceptably low blood sugars	-0.14	—
4) Convenience of treatment	0.88	—
5) Flexibility of current treatment	0.86	—
6) Satisfaction with understanding of diabetes	0.84	—
7) Recommending treatment to others	0.94	—
8) Satisfaction to continue with present treatment	1.11	—
Total treatment satisfaction score	5.81	—

Secondary/protocol endpoint

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Time frame:Week 0, week 52

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in DTSQ

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch

Time frame:Week 52, week 104

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in DTSQ- Switch

Time frame:Week 52, week 104

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability

Time frame:Week 0, week 104

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in DTSQ- Sustainability

Time frame:Week 0, week 104

change from baseline, improvement

Safety / tolerability / PK

30 endpoints

Secondary/registry result

Number of TEAEs During Exposure to Trial Product

Time frame:Week 0-57

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide Flex- Main Phase	768	—
Sitagliptin 100 mg- Main Phase	519	—

Secondary/registry result

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0-57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Oral Semaglutide Flex- Main Phase	34	—
Sitagliptin 100 mg- Main Phase	22	—

Secondary/registry result

Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)

Time frame:Week 0-57

Severe hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Main Phase	14	—
Sitagliptin 100 mg- Main Phase	14	—

Secondary/registry result

Change in Amylase (Ratio to Baseline)

Time frame:Week 0, Week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Oral Semaglutide Flex- Main Phase	1.14	—
Sitagliptin 100 mg- Main Phase	1.08	—

Secondary/registry result

Change in Lipase (Ratio to Baseline)

Time frame:Week 0, Week 52

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Oral Semaglutide Flex- Main Phase	1.24	—
Sitagliptin 100 mg- Main Phase	1.13	—

Secondary/registry result

Number of TEAEs During Exposure to Trial Product- Switch

Time frame:Week 53-109

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide Flex- Switch	267	—
Sitagliptin 100 mg- Switch	225	—

Secondary/registry result

Change in Amylase (Ratio to Baseline)- Switch

Time frame:Week 52, Week 104

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Oral Semaglutide Flex- Switch	1.09	—
Sitagliptin 100 mg- Switch	1.00	—

Secondary/registry result

Change in Lipase (Ratio to Baseline)- Switch

Time frame:Week 52, Week 104

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Oral Semaglutide Flex- Switch	1.13	—
Sitagliptin 100 mg- Switch	0.92	—

Secondary/registry result

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch

Time frame:Week 53-109

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Oral Semaglutide Flex- Switch	2	—
Sitagliptin 100 mg- Switch	12	—

Secondary/registry result

Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch

Time frame:Week 53-109

Documented hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Switch	2	—
Sitagliptin 100 mg- Switch	4	—

Secondary/registry result

Number of TEAEs During Exposure to Trial Product- Sustainability

Time frame:Week 0-109

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide Flex- Sustainability	1157	—

Secondary/registry result

Change in Amylase (Ratio to Baseline)- Sustainability

Time frame:Week 0, week 104

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Oral Semaglutide Flex- Sustainability	1.13	—

Secondary/registry result

Change in Lipase (Ratio to Baseline)- Sustainability

Time frame:Week 0, Week 104

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Oral Semaglutide Flex- Sustainability	1.18	—

Secondary/registry result

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability

Time frame:Week 0-109

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Oral Semaglutide Flex- Sustainability	45	—

Secondary/registry result

Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability

Time frame:Week 0-109

Severe hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide Flex- Sustainability	18	—

Secondary/protocol endpoint

Number of TEAEs During Exposure to Trial Product

Time frame:Week 0-57

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0-57

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)

Time frame:Week 0-57

Severe hypoglycemia

categorical status, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change in Amylase (Ratio to Baseline)

Time frame:Week 0, Week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase (Ratio to Baseline)

Time frame:Week 0, Week 52

ratio, descriptive

Secondary/protocol endpoint

Number of TEAEs During Exposure to Trial Product- Switch

Time frame:Week 53-109

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in Amylase (Ratio to Baseline)- Switch

Time frame:Week 52, Week 104

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase (Ratio to Baseline)- Switch

Time frame:Week 52, Week 104

ratio, descriptive

Secondary/protocol endpoint

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch

Time frame:Week 53-109

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch

Time frame:Week 53-109

Severe hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of TEAEs During Exposure to Trial Product- Sustainability

Time frame:Week 0-109

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in Amylase (Ratio to Baseline)- Sustainability

Time frame:Week 0, week 104

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase (Ratio to Baseline)- Sustainability

Time frame:Week 0, Week 104

ratio, descriptive

Secondary/protocol endpoint

Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability

Time frame:Week 0-109

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability

Time frame:Week 0-109

Documented hypoglycemia

threshold achievement, event

Publications (7)

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 by subgroups of patient characteristics in the PIONEER phase 3 programme.
Diabetes, obesity & metabolism2022 Jul (month)PMID35373893doi:10.1111/dom.14710via CT.gov reference
Oral Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses.
Diabetes therapy : research, treatment and education of diabetes and related disorders2021 Apr (month)PMID33660198doi:10.1007/s13300-020-00994-9via clinicaltrials gov reference derived + pubmed nct search
Long-term efficacy and safety of oral semaglutide and the effect of switching from sitagliptin to oral semaglutide in patients with type 2 diabetes: a 52-week, randomized, open-label extension of the PIONEER 7 trial.
BMJ open diabetes research & care2020 Dec (month)PMID33318068doi:10.1136/bmjdrc-2020-001649via CT.gov reference + pubmed nct search
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Cardiovascular diabetology2020 Sep 30PMID32998732doi:10.1186/s12933-020-01106-4via clinicaltrials gov reference derived + pubmed nct search
Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.
Diabetes, obesity & metabolism2020 Aug (month)PMID32267058doi:10.1111/dom.14054via clinicaltrials gov reference derived + pubmed nct search
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Diabetes, obesity & metabolism2020 Mar (month)PMID31903692doi:10.1111/dom.13955via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial.
The lancet. Diabetes & endocrinology2019 Jul (month)PMID31189520doi:10.1016/S2213-8587(19)30194-9via CT.gov reference + 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.