GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

150

Recruiting sites

—

Enrollment

706

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI 25-40

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 IDNCT02461589

Org study IDNN9535-4191

Secondary ID2014-003196-39

Secondary IDU1111-1159-4923WHO

Timeline

Milestones

Study first posted2015-06-03estimated

Study start2015-09-21actual

Primary completion2016-10-13actual

Study completion2016-10-13actual

Results first posted2018-01-23actual

Last update posted2019-07-31actual

Assets

Investigational agents

Liraglutide Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening

•HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)

•BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Exclusion criteria

•Simultaneous participation in any other clinical trial of an investigational medicinal product

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)

•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 screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)

•Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

•History of pancreatitis (acute or chronic)

•Screening calcitonin above or equal to 50 ng/L

•Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

•Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)

•Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack

•Currently planned coronary, carotid or peripheral artery revascularisation

•Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

Endpoints (8)

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

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/registry result

Body Weight Change

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Semaglutide 0.05 mg/Day	-2.75	—
Semaglutide 0.1 mg/Day	-4.36	—
Semaglutide 0.2 mg/Day	-6.70	—
Semaglutide 0.3 mg/Day	-8.23	—
Liraglutide 0.3 mg/Day	-1.48	—
Liraglutide 0.6 mg/Day	-1.81	—
Liraglutide 1.2 mg/Day	-1.78	—
Liraglutide 1.8 mg/Day	-3.68	—
Placebo	-1.22	—
Semaglutide Flexible	-6.60	—

Secondary/protocol endpoint

Body Weight Change

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

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 glycosylated haemoglobin	95% CI
Semaglutide 0.05 mg/Day	-0.97	—
Semaglutide 0.1 mg/Day	-1.30	—
Semaglutide 0.2 mg/Day	-1.65	—
Semaglutide 0.3 mg/Day	-1.96	—
Liraglutide 0.3 mg/Day	-0.50	—
Liraglutide 0.6 mg/Day	-0.88	—
Liraglutide 1.2 mg/Day	-0.86	—
Liraglutide 1.8 mg/Day	-1.32	—
Placebo	-0.05	—
Semaglutide Flexible	-1.72	—

Treatment difference-1.0495% CI-1.30 – -0.77p<0.0001Mixed Models Analysis

Treatment difference-1.3495% CI-1.61 – -1.08p<0.0001Mixed Models Analysis

Treatment difference-1.6995% CI-1.95 – -1.42p<0.0001Mixed Models Analysis

Treatment difference-1.8695% CI-2.12 – -1.60p<0.0001Mixed 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

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 0.05 mg/Day	-2.09	—
Semaglutide 0.1 mg/Day	-2.08	—
Semaglutide 0.2 mg/Day	-2.64	—
Semaglutide 0.3 mg/Day	-3.53	—
Liraglutide 0.3 mg/Day	-1.33	—
Liraglutide 0.6 mg/Day	-1.56	—
Liraglutide 1.2 mg/Day	-1.51	—
Liraglutide 1.8 mg/Day	-1.92	—
Placebo	-0.54	—
Semaglutide Flexible	-3.40	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Change in Systolic and Diastolic Blood Pressure

Time frame:Week 0, Week 26

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 0.05 mg/DaySystolicblood pressure	-5.74	—
Diastolic blood pressure	-0.60	—
Semaglutide 0.1 mg/DaySystolicblood pressure	-2.77	—
Diastolic blood pressure	0.66	—
Semaglutide 0.2 mg/DaySystolicblood pressure	-4.25	—
Diastolic blood pressure	-1.62	—
Semaglutide 0.3 mg/DaySystolicblood pressure	-9.85	—
Diastolic blood pressure	-4.02	—
Liraglutide 0.3 mg/DaySystolicblood pressure	-3.77	—
Diastolic blood pressure	-1.77	—
Liraglutide 0.6 mg/DaySystolicblood pressure	-3.20	—
Diastolic blood pressure	-1.89	—
Liraglutide 1.2 mg/DaySystolicblood pressure	-4.69	—
Diastolic blood pressure	-0.60	—
Liraglutide 1.8 mg/DaySystolicblood pressure	-2.99	—
Diastolic blood pressure	0.63	—
PlaceboSystolicblood pressure	-2.34	—
Diastolic blood pressure	-0.61	—
Semaglutide FlexibleSystolicblood pressure	-6.62	—
Diastolic blood pressure	-1.69	—

Secondary/protocol endpoint

Change in Systolic and Diastolic Blood Pressure

Time frame:Week 0, Week 26

change from baseline, improvement

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

A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin.
Diabetes care2018 Sep (month)PMID30026333doi:10.2337/dc17-2381via 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.