NCT00696657 is a Phase 2 clinical trial of semaglutide in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT00696657?

NCT00696657 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT00696657?

Interventions in NCT00696657: semaglutide, semaglutide, semaglutide, semaglutide, semaglutide, semaglutide, placebo, placebo, placebo, placebo, placebo, liraglutide, liraglutide.

What condition does NCT00696657 study?

NCT00696657 studies Diabetes, Diabetes Mellitus, Type 2.

Is NCT00696657 still recruiting?

NCT00696657 is currently completed. Last updated 14 August 2019.

Are results published for NCT00696657?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-14 · How we verify

NCT00696657

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Completed Phase 2 Results posted Last updated 14 August 2019

What this trial tests

Phase 2 trial testing semaglutide in Diabetes in 415 participants. Completed in 5 February 2009.

Timeline

3 June 2008

Primary endpoint
5 February 2009

5 February 2009

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	415
Start date	3 June 2008
Primary completion	5 February 2009
Estimated completion	5 February 2009
Sites	77 locations across France, Italy, Finland, South Africa, Serbia and Montenegro, Austria, United Kingdom, Germany

Drugs / interventions tested

semaglutide (semaglutide) — full drug profile →
semaglutide (semaglutide) — full drug profile →
semaglutide (semaglutide) — full drug profile →
semaglutide (semaglutide) — full drug profile →
semaglutide (semaglutide) — full drug profile →
semaglutide (semaglutide) — full drug profile →
placebo
placebo
placebo
placebo
placebo
liraglutide (liraglutide) — full drug profile →
liraglutide (liraglutide) — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HbA1c Primary · After 12 weeks of treatment.

Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.

Group	Value	95% CI
Placebo	-0.5	± 0.8
Semaglutide 0.1 mg	-0.6	± 0.7
Semaglutide 0.2 mg	-0.9	± 0.9
Semaglutide 0.4 mg	-1.0	± 0.8
Semaglutide 0.8 mg	-1.4	± 0.8
Semaglutide 0.8 mg (With Titration)	-1.4	± 1.0
Semaglutide 1.6 mg (With Titration)	-1.5	± 0.8
Liraglutide 1.2 mg	-1.1	± 0.7
Liraglutide 1.8 mg	-1.3	± 0.7

Percentage of Subjects With an Adverse Events Secondary · After 12 weeks of treatment.

The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.

Group	Value	95% CI
Placebo	43.5
Semaglutide 0.1 mg	59.6
Semaglutide 0.2 mg	55.8
Semaglutide 0.4 mg	72.9
Semaglutide 0.8 mg	85.7
Semaglutide 0.8 mg (With Titration)	72.1
Semaglutide 1.6 mg (With Titration)	93.6
Liraglutide 1.2 mg	55.6
Liraglutide 1.8 mg	62.0

Percentage of Subjects With Hypoglycaemic Episode Secondary · After 12 weeks of treatment

The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was \<3.1 mmol

Major

Group	Value	95% CI
Placebo	0
Semaglutide 0.1 mg	0
Semaglutide 0.2 mg	0
Semaglutide 0.4 mg	0
Semaglutide 0.8 mg	0
Semaglutide 0.8 mg (With Titration)	0
Semaglutide 1.6 mg (With Titration)	0
Liraglutide 1.2 mg	0
Liraglutide 1.8 mg	0

Minor

Group	Value	95% CI
Placebo	0
Semaglutide 0.1 mg	4.3
Semaglutide 0.2 mg	0
Semaglutide 0.4 mg	4.2
Semaglutide 0.8 mg	0
Semaglutide 0.8 mg (With Titration)	2.3
Semaglutide 1.6 mg (With Titration)	0
Liraglutide 1.2 mg	4.4
Liraglutide 1.8 mg	2.0

Symptoms only

Group	Value	95% CI
Placebo	2.2
Semaglutide 0.1 mg	2.1
Semaglutide 0.2 mg	2.3
Semaglutide 0.4 mg	0
Semaglutide 0.8 mg	0
Semaglutide 0.8 mg (With Titration)	0
Semaglutide 1.6 mg (With Titration)	6.4
Liraglutide 1.2 mg	8.9
Liraglutide 1.8 mg	2.0

Change From Baseline in ECG Secondary · Week 0, week 12.

A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as "week -2, week 12". Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant \[NCS\] or abnormal clinically significant \[CS\]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12).

Week -2: Normal

Group	Value	95% CI
Placebo	42
Semaglutide 0.1 mg	33
Semaglutide 0.2 mg	37
Semaglutide 0.4 mg	34
Semaglutide 0.8 mg	31
Semaglutide 0.8 mg (With Titration)	28
Semaglutide 1.6 mg (With Titration)	37
Liraglutide 1.2 mg	39
Liraglutide 1.8 mg	41

Week -2: Abnormal, NCS

Group	Value	95% CI
Placebo	4
Semaglutide 0.1 mg	14
Semaglutide 0.2 mg	6
Semaglutide 0.4 mg	12
Semaglutide 0.8 mg	10
Semaglutide 0.8 mg (With Titration)	15
Semaglutide 1.6 mg (With Titration)	8
Liraglutide 1.2 mg	6
Liraglutide 1.8 mg	9

Week -2: Abnormal, CS

Group	Value	95% CI
Placebo	0
Semaglutide 0.1 mg	0
Semaglutide 0.2 mg	0
Semaglutide 0.4 mg	2
Semaglutide 0.8 mg	1
Semaglutide 0.8 mg (With Titration)	0
Semaglutide 1.6 mg (With Titration)	2
Liraglutide 1.2 mg	0
Liraglutide 1.8 mg	0

Week 12: Normal

Group	Value	95% CI
Placebo	39
Semaglutide 0.1 mg	32
Semaglutide 0.2 mg	34
Semaglutide 0.4 mg	36
Semaglutide 0.8 mg	29
Semaglutide 0.8 mg (With Titration)	33
Semaglutide 1.6 mg (With Titration)	36
Liraglutide 1.2 mg	37
Liraglutide 1.8 mg	42

Week 12: Abnormal, NCS

Group	Value	95% CI
Placebo	6
Semaglutide 0.1 mg	14
Semaglutide 0.2 mg	3
Semaglutide 0.4 mg	7
Semaglutide 0.8 mg	7
Semaglutide 0.8 mg (With Titration)	9
Semaglutide 1.6 mg (With Titration)	5
Liraglutide 1.2 mg	6
Liraglutide 1.8 mg	5

Week 12: Abnormal, CS

Group	Value	95% CI
Placebo	0
Semaglutide 0.1 mg	0
Semaglutide 0.2 mg	1
Semaglutide 0.4 mg	2
Semaglutide 0.8 mg	1
Semaglutide 0.8 mg (With Titration)	0
Semaglutide 1.6 mg (With Titration)	3
Liraglutide 1.2 mg	0
Liraglutide 1.8 mg	0

Week 12: ECG not done (ND)

Group	Value	95% CI
Placebo	1
Semaglutide 0.1 mg	1
Semaglutide 0.2 mg	5
Semaglutide 0.4 mg	1
Semaglutide 0.8 mg	3
Semaglutide 0.8 mg (With Titration)	1
Semaglutide 1.6 mg (With Titration)	2
Liraglutide 1.2 mg	2
Liraglutide 1.8 mg	2

Change From Baseline in Vital Signs (Pulse) Secondary · Week 0, week 12

Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	0.5	± 8.9
Semaglutide 0.1 mg	-0.0	± 7.6
Semaglutide 0.2 mg	0.5	± 13.8
Semaglutide 0.4 mg	1.5	± 8.5
Semaglutide 0.8 mg	1.5	± 9.6
Semaglutide 0.8 mg (With Titration)	2.9	± 11.9
Semaglutide 1.6 mg (With Titration)	3.9	± 12.6
Liraglutide 1.2 mg	4.4	± 10.2
Liraglutide 1.8 mg	2.1	± 10.1

Change From Baseline in Vital Signs (Blood Pressure; SBP) Secondary · Week 0, week 12

Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	-3.2	± 14.8
Semaglutide 0.1 mg	3.3	± 11.0
Semaglutide 0.2 mg	-2.5	± 14.1
Semaglutide 0.4 mg	-3.6	± 13.1
Semaglutide 0.8 mg	-6.7	± 14.9
Semaglutide 0.8 mg (With Titration)	-7.7	± 13.0
Semaglutide 1.6 mg (With Titration)	-5.9	± 11.6
Liraglutide 1.2 mg	-2.9	± 12.0
Liraglutide 1.8 mg	-5.4	± 14.0

Change From Baseline in Vital Signs (Blood Pressure; DBP) Secondary · Week 0, week 12

Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	-2.3	± 9.8
Semaglutide 0.1 mg	1.5	± 7.9
Semaglutide 0.2 mg	-0.4	± 8.5
Semaglutide 0.4 mg	-1.5	± 9.7
Semaglutide 0.8 mg	-1.5	± 7.9
Semaglutide 0.8 mg (With Titration)	-2.3	± 9.7
Semaglutide 1.6 mg (With Titration)	-3.0	± 7.7
Liraglutide 1.2 mg	-2.1	± 10.0
Liraglutide 1.8 mg	-0.0	± 8.8

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) Secondary · Week 0, week 12

Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	-0.0	± 0.0
Semaglutide 0.1 mg	0.0	± 0.0
Semaglutide 0.2 mg	-0.0	± 0.0
Semaglutide 0.4 mg	0.0	± 0.0
Semaglutide 0.8 mg	-0.0	± 0.0
Semaglutide 0.8 mg (With Titration)	-0.0	± 0.0
Semaglutide 1.6 mg (With Titration)	-0.0	± 0.0
Liraglutide 1.2 mg	0.0	± 0.0
Liraglutide 1.8 mg	0.0	± 0.0

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) Secondary · Week 0, week 12

Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	-0.0	± 0.2
Semaglutide 0.1 mg	0.0	± 0.2
Semaglutide 0.2 mg	-0.0	± 0.1
Semaglutide 0.4 mg	0.0	± 0.1
Semaglutide 0.8 mg	-0.0	± 0.2
Semaglutide 0.8 mg (With Titration)	0.0	± 0.3
Semaglutide 1.6 mg (With Titration)	0.1	± 0.2
Liraglutide 1.2 mg	0.0	± 0.2
Liraglutide 1.8 mg	-0.0	± 0.1

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) Secondary · Week 0, week 12

Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	-0.01	± 0.02
Semaglutide 0.1 mg	-0.01	± 0.03
Semaglutide 0.2 mg	-0.01	± 0.03
Semaglutide 0.4 mg	0.00	± 0.03
Semaglutide 0.8 mg	-0.01	± 0.02
Semaglutide 0.8 mg (With Titration)	-0.00	± 0.03
Semaglutide 1.6 mg (With Titration)	-0.00	± 0.03
Liraglutide 1.2 mg	0.00	± 0.03
Liraglutide 1.8 mg	-0.01	± 0.03

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) Secondary · Week 0, week 12

Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	0.1	± 6.3
Semaglutide 0.1 mg	-0.4	± 5.9
Semaglutide 0.2 mg	-1.2	± 9.3
Semaglutide 0.4 mg	2.8	± 9.5
Semaglutide 0.8 mg	-0.3	± 7.7
Semaglutide 0.8 mg (With Titration)	1.5	± 6.9
Semaglutide 1.6 mg (With Titration)	1.0	± 7.1
Liraglutide 1.2 mg	2.1	± 6.7
Liraglutide 1.8 mg	1.1	± 10.7

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) Secondary · Week 0, week 12

Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Group	Value	95% CI
Placebo	-0.1	± 0.6
Semaglutide 0.1 mg	0.0	± 0.4
Semaglutide 0.2 mg	-0.1	± 0.6
Semaglutide 0.4 mg	0.2	± 0.9
Semaglutide 0.8 mg	-0.0	± 0.7
Semaglutide 0.8 mg (With Titration)	-0.1	± 0.7
Semaglutide 1.6 mg (With Titration)	0.1	± 0.5
Liraglutide 1.2 mg	0.0	± 0.4
Liraglutide 1.8 mg	-0.1	± 0.8

Adverse events — posted to ClinicalTrials.gov

Time frame: The results for adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/46 (2%)

Deaths: 0/46

Semaglutide 0.1 mg

Serious: 1/47 (2%)

Deaths: 0/47

Semaglutide 0.2 mg

Serious: 1/43 (2%)

Deaths: 0/43

Semaglutide 0.4 mg

Serious: 2/48 (4%)

Deaths: 0/48

Semaglutide 0.8 mg

Serious: 0/42 (0%)

Deaths: 0/42

Semaglutide 0.8 mg (With Titration)

Serious: 1/43 (2%)

Deaths: 0/43

Semaglutide 1.6 mg (With Titration)

Serious: 2/47 (4%)

Deaths: 0/47

Liraglutide 1.2 mg

Serious: 0/45 (0%)

Deaths: 0/45

Liraglutide 1.8 mg

Serious: 0/50 (0%)

Deaths: 0/50

Serious adverse events (9 terms)

Reaction	System	Placebo	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Semaglutide 0.8 mg	Semaglutide 0.8 mg (With T…	Semaglutide 1.6 mg (With T…	Liraglutide 1.2 mg	Liraglutide 1.8 mg
Acute left ventricular failure	Cardiac disorders	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—
Arterial occlusive disease	Vascular disorders	—	—	—	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—	—	—	—
Epilepsy	Nervous system disorders	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	Placebo	Semaglutide 0.1 mg	Semaglutide 0.2 mg	Semaglutide 0.4 mg	Semaglutide 0.8 mg	Semaglutide 0.8 mg (With T…	Semaglutide 1.6 mg (With T…	Liraglutide 1.2 mg	Liraglutide 1.8 mg
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diabetic retinopathy	Eye disorders	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Acute left ventricular failure, Acute myocardial infarction, Arterial occlusive disease, Coronary artery disease, Epilepsy, Herpes zoster, Hypertension, Myocardial infarction.

Data from ClinicalTrials.gov NCT00696657 adverse events section.

Sponsor's own description

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Glucagon-like peptide analogues for type 2 diabetes mellitus.
Shyangdan DS, Royle P, Clar C, Sharma P, et al · · 2011 · cited 123× · PMID 21975753 · DOI 10.1002/14651858.cd006423.pub2
Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
Mahapatra MK, Karuppasamy M, Sahoo BM. · · 2022 · cited 92× · PMID 34993760 · DOI 10.1007/s11154-021-09699-1
Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials.
Monami M, Cremasco F, Lamanna C, Colombi C, et al · · 2011 · cited 76× · PMID 21584276 · DOI 10.1155/2011/215764
Efficacy and tolerability of the Subcutaneous Semaglutide for type 2 Diabetes patients: an updated systematic review and meta-analysis.
Hu S, Su X, Fan G. · · 2023 · cited 16× · PMID 37891683 · DOI 10.1186/s13098-023-01195-7
Liraglutide for the Treatment of Type 2 Diabetes and Safety in Diabetic Kidney Disease: Liraglutide and Diabetic Kidney Disease.
Cherney DZ, Tuttle KR. · · 2020 · cited 9× · PMID 32149722 · DOI 10.2215/cjn.01260120

Verify or expand the search:

Other trials of semaglutide

Trials testing the same drug.

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Other recruiting trials for Diabetes

Currently open trials in the same condition.

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Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00696657 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 14 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00696657.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing