GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01923181

CompletedPhase 2Results posted

Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

103

Recruiting sites

—

Enrollment

632

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c 7-9.5%

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 IDNCT01923181

Org study IDNN9924-3790

Secondary ID2012-004994-16

Secondary IDU1111-1136-4716WHO

Timeline

Milestones

Study first posted2013-08-15estimated

Study start2013-12-02actual

Primary completion2014-12-11actual

Study completion2014-12-11actual

Results first posted2019-11-05actual

Last update posted2021-01-15actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•BMI above or equal to 25 and below or equal to 40 kg/m^2

•Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening

•HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

Exclusion criteria

•Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Chronic malabsorption, regardless of aetiology

•History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease

•Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit

Endpoints (14)

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

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

6 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Oral Semaglutide 2.5 mg	-2.01	—
Oral Semaglutide 5 mg	-2.89	—
Oral Semaglutide 10 mg	-4.90	—
Oral Semaglutide 20 mg	-5.75	—
Oral Semaglutide 40 mg	-6.91	—
Oral Semaglutide 40 mg Slow Dose-escalation	-5.93	—
Oral Semaglutide 40 mg Fast Dose-escalation	-8.29	—
Subcutaneous Semaglutide 1 mg	-6.71	—
Placebo	-1.16	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Oral Semaglutide 2.5 mg	-2.00	—
Oral Semaglutide 5 mg	-2.29	—
Oral Semaglutide 10 mg	-5.28	—
Oral Semaglutide 20 mg	-4.08	—
Oral Semaglutide 40 mg	-5.71	—
Oral Semaglutide 40 mg Slow Dose-escalation	-4.86	—
Oral Semaglutide 40 mg Fast Dose-escalation	-6.24	—
Subcutaneous Semaglutide 1 mg	-6.34	—
Placebo	-2.29	—

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, week 26

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Oral Semaglutide 2.5 mg	-0.67	—
Oral Semaglutide 5 mg	-0.98	—
Oral Semaglutide 10 mg	-1.72	—
Oral Semaglutide 20 mg	-1.93	—
Oral Semaglutide 40 mg	-2.37	—
Oral Semaglutide 40 mg Slow Dose-escalation	-2.04	—
Oral Semaglutide 40 mg Fast Dose-escalation	-2.92	—
Subcutaneous Semaglutide 1 mg	-2.32	—
Placebo	-0.43	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Week 0, week 26

BMI, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/registry result

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide 2.5 mg	-0.88	—
Oral Semaglutide 5 mg	-1.23	—
Oral Semaglutide 10 mg	-1.56	—
Oral Semaglutide 20 mg	-1.70	—
Oral Semaglutide 40 mg	-2.04	—
Oral Semaglutide 40 mg Slow Dose-escalation	-1.76	—
Oral Semaglutide 40 mg Fast Dose-escalation	-1.65	—
Oral Semaglutide 40 mg Pooled	-1.85	—
Subcutaneous Semaglutide 1 mg	-1.85	—
Placebo	-0.40	—

Mean treatment difference-1.4795% CI-1.73 – -1.22p<0.0001Mixed Models Analysis

Treatment difference-0.4095% CI-0.69 – -0.11p0.0069Mixed Models Analysis

Treatment difference-0.8995% CI-1.18 – -0.60p<0.0001Mixed Models Analysis

Treatment difference-1.1895% CI-1.47 – -0.90p<0.0001Mixed Models Analysis

Treatment difference-1.3895% CI-1.68 – -1.09p<0.0001Mixed Models Analysis

Treatment difference-1.6095% CI-1.89 – -1.30p<0.0001Mixed Models Analysis

Treatment difference-1.4395% CI-1.72 – -1.14p<0.0001Mixed Models Analysis

Treatment difference-1.3495% CI-1.64 – -1.04p<0.0001Mixed Models Analysis

Treatment difference-1.5695% CI-1.85 – -1.27p<0.0001Mixed Models Analysis

Treatment difference1.1695% CI0.87 – 1.45p<0.0001Mixed Models Analysis

Treatment difference0.6795% CI0.38 – 0.96p<0.0001Mixed Models Analysis

Treatment difference0.3795% CI0.08 – 0.67p0.0116Mixed Models Analysis

Treatment difference0.1895% CI-0.12 – 0.47p0.2440Mixed Models Analysis

Treatment difference-0.0495% CI-0.34 – 0.26p0.7973Mixed Models Analysis

Treatment difference0.1395% CI-0.16 – 0.42p0.3901Mixed Models Analysis

Treatment difference0.2295% CI-0.09 – 0.52p0.1612Mixed Models Analysis

Treatment difference0.1795% CI-0.13 – 0.46p0.2669Mixed Models Analysis

Treatment difference0.2695% CI-0.05 – 0.56p0.0989Mixed Models Analysis

Treatment difference0.0995% CI-0.21 – 0.39p0.5565Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 2.5 mgYes	27	—
No	29	—
Oral Semaglutide 5 mgYes	50	—
No	8	—
Oral Semaglutide 10 mgYes	49	—
No	8	—
Oral Semaglutide 20 mgYes	41	—
No	7	—
Oral Semaglutide 40 mgYes	42	—
No	4	—
Oral Semaglutide 40 mg Slow Dose-escalationYes	47	—
No	5	—
Oral Semaglutide 40 mg Fast Dose-escalationYes	38	—
No	6	—
Subcutaneous Semaglutide 1 mgYes	45	—
No	3	—
PlaceboYes	18	—
No	33	—

Secondary/protocol endpoint

Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs) Recorded

Time frame:Weeks 0-31

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 2.5 mg	142	—
Oral Semaglutide 5 mg	169	—
Oral Semaglutide 10 mg	233	—
Oral Semaglutide 20 mg	289	—
Oral Semaglutide 40 mg	230	—
Oral Semaglutide 40 mg Slow Dose-escalation	233	—
Oral Semaglutide 40 mg Fast Dose-escalation	245	—
Subcutaneous Semaglutide 1 mg	218	—
Placebo	127	—

Secondary/registry result

Number of Confirmed Hypoglycaemic Episodes Recorded

Time frame:Weeks 0-31

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Oral Semaglutide 2.5 mg	4	—
Oral Semaglutide 5 mg	4	—
Oral Semaglutide 10 mg	6	—
Oral Semaglutide 20 mg	1	—
Oral Semaglutide 40 mg	1	—
Oral Semaglutide 40 mg Slow Dose-escalation	3	—
Oral Semaglutide 40 mg Fast Dose-escalation	1	—
Subcutaneous Semaglutide 1 mg	6	—
Placebo	5	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs) Recorded

Time frame:Weeks 0-31

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Confirmed Hypoglycaemic Episodes Recorded

Time frame:Weeks 0-31

Documented hypoglycemia

event count, event

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

Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
JAMA2017 Oct 17PMID29049653doi:10.1001/jama.2017.14752via 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.