NCT02461589 is a Phase 2 clinical trial of semaglutide in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT02461589?

NCT02461589 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT02461589?

Interventions in NCT02461589: semaglutide, liraglutide, placebo.

What condition does NCT02461589 study?

NCT02461589 studies Diabetes, Diabetes Mellitus, Type 2.

Is NCT02461589 still recruiting?

NCT02461589 is currently completed. Last updated 31 July 2019.

Are results published for NCT02461589?

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

Last reviewed 2019-07-31 · How we verify

NCT02461589

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

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

Completed Phase 2 Results posted Last updated 31 July 2019

What this trial tests

Phase 2 trial testing semaglutide in Diabetes in 706 participants. Completed in 13 October 2016.

Timeline

21 September 2015

Primary endpoint
13 October 2016

13 October 2016

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	706
Start date	21 September 2015
Primary completion	13 October 2016
Estimated completion	13 October 2016
Sites	150 locations across South Africa, Russia, Malaysia, Serbia, Austria, United Kingdom, Germany, Canada

Drugs / interventions tested

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

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.

Change in HbA1c (Glycosylated Haemoglobin) Primary · Week 0, week 26

Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Group	Value	95% CI
Semaglutide 0.05 mg/Day	-0.97	± 0.85
Semaglutide 0.1 mg/Day	-1.30	± 1.03
Semaglutide 0.2 mg/Day	-1.65	± 0.79
Semaglutide 0.3 mg/Day	-1.96	± 0.95
Liraglutide 0.3 mg/Day	-0.50	± 0.93
Liraglutide 0.6 mg/Day	-0.88	± 0.90
Liraglutide 1.2 mg/Day	-0.86	± 0.92
Liraglutide 1.8 mg/Day	-1.32	± 0.78
Placebo	-0.05	± 0.90
Semaglutide Flexible	-1.72	± 0.97

Change in Fasting Plasma Glucose (FPG) Secondary · Week 0, Week 26

Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Group	Value	95% CI
Semaglutide 0.05 mg/Day	-2.09	± 1.96
Semaglutide 0.1 mg/Day	-2.08	± 2.23
Semaglutide 0.2 mg/Day	-2.64	± 2.07
Semaglutide 0.3 mg/Day	-3.53	± 2.20
Liraglutide 0.3 mg/Day	-1.33	± 2.06
Liraglutide 0.6 mg/Day	-1.56	± 1.74
Liraglutide 1.2 mg/Day	-1.51	± 2.41
Liraglutide 1.8 mg/Day	-1.92	± 2.34
Placebo	-0.54	± 2.45
Semaglutide Flexible	-3.40	± 2.84

Body Weight Change Secondary · Week 0, Week 26

The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Group	Value	95% CI
Semaglutide 0.05 mg/Day	-2.75	± 2.82
Semaglutide 0.1 mg/Day	-4.36	± 4.24
Semaglutide 0.2 mg/Day	-6.70	± 4.57
Semaglutide 0.3 mg/Day	-8.23	± 5.34
Liraglutide 0.3 mg/Day	-1.48	± 3.06
Liraglutide 0.6 mg/Day	-1.81	± 3.06
Liraglutide 1.2 mg/Day	-1.78	± 3.41
Liraglutide 1.8 mg/Day	-3.68	± 4.26
Placebo	-1.22	± 3.42
Semaglutide Flexible	-6.60	± 4.98

Change in Systolic and Diastolic Blood Pressure Secondary · Week 0, Week 26

Systolicblood pressure

Group	Value	95% CI
Semaglutide 0.05 mg/Day	-5.74	± 12.30
Semaglutide 0.1 mg/Day	-2.77	± 13.21
Semaglutide 0.2 mg/Day	-4.25	± 12.24
Semaglutide 0.3 mg/Day	-9.85	± 11.58
Liraglutide 0.3 mg/Day	-3.77	± 9.79
Liraglutide 0.6 mg/Day	-3.20	± 10.89
Liraglutide 1.2 mg/Day	-4.69	± 12.73
Liraglutide 1.8 mg/Day	-2.99	± 11.94
Placebo	-2.34	± 11.40
Semaglutide Flexible	-6.62	± 14.02

Diastolic blood pressure

Group	Value	95% CI
Semaglutide 0.05 mg/Day	-0.60	± 8.78
Semaglutide 0.1 mg/Day	0.66	± 8.26
Semaglutide 0.2 mg/Day	-1.62	± 9.38
Semaglutide 0.3 mg/Day	-4.02	± 8.56
Liraglutide 0.3 mg/Day	-1.77	± 7.37
Liraglutide 0.6 mg/Day	-1.89	± 8.20
Liraglutide 1.2 mg/Day	-0.60	± 6.78
Liraglutide 1.8 mg/Day	0.63	± 8.13
Placebo	-0.61	± 8.50
Semaglutide Flexible	-1.69	± 8.25

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline up to week 33.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Semaglutide 0.05 mg/Day

Serious: 7/64 (11%)

Deaths: —

Semaglutide 0.1 mg/Day

Serious: 3/63 (5%)

Deaths: —

Semaglutide 0.2 mg/Day

Serious: 2/65 (3%)

Deaths: —

Semaglutide 0.3 mg/Day

Serious: 2/63 (3%)

Deaths: —

Liraglutide 0.3 mg/Day

Serious: 1/64 (2%)

Deaths: —

Liraglutide 0.6 mg/Day

Serious: 2/64 (3%)

Deaths: —

Liraglutide 1.2 mg/Day

Serious: 2/64 (3%)

Deaths: —

Liraglutide 1.8 mg/Day

Serious: 7/65 (11%)

Deaths: —

Placebo

Serious: 0/129 (0%)

Deaths: —

Semaglutide Flexible

Serious: 4/64 (6%)

Deaths: —

Serious adverse events (41 terms)

Reaction	System	Semaglutide 0.05 mg/Day	Semaglutide 0.1 mg/Day	Semaglutide 0.2 mg/Day	Semaglutide 0.3 mg/Day	Liraglutide 0.3 mg/Day	Liraglutide 0.6 mg/Day	Liraglutide 1.2 mg/Day	Liraglutide 1.8 mg/Day	Placebo	Semaglutide Flexible
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Anal fistula	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Arteriosclerosis	Vascular disorders	—	—	—	—	—	—	—	—	—	—
Atrioventricular block complete	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Bundle branch block left	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Carotid artery stenosis	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Catheterisation cardiac	Investigations	—	—	—	—	—	—	—	—	—	—
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Coronary revascularisation	Surgical and medical procedures	—	—	—	—	—	—	—	—	—	—
Cystoscopy	Investigations	—	—	—	—	—	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Endarterectomy	Surgical and medical procedures	—	—	—	—	—	—	—	—	—	—
Endometrial hyperplasia	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—
Escherichia pyelonephritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Percutaneous coronary intervention	Surgical and medical procedures	—	—	—	—	—	—	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—

Other adverse events (25 terms — click to expand)

Reaction	System	Semaglutide 0.05 mg/Day	Semaglutide 0.1 mg/Day	Semaglutide 0.2 mg/Day	Semaglutide 0.3 mg/Day	Liraglutide 0.3 mg/Day	Liraglutide 0.6 mg/Day	Liraglutide 1.2 mg/Day	Liraglutide 1.8 mg/Day	Placebo	Semaglutide Flexible
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abortion spontaneous, Acute myocardial infarction, Adenocarcinoma of colon, Anal fistula, Arteriosclerosis, Atrioventricular block complete, Back pain, Bundle branch block left.

Data from ClinicalTrials.gov NCT02461589 adverse events section.

Sponsor's own description

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

Publications & conference data

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

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
Metabolic and cardiovascular benefits of GLP-1 agonists, besides the hypoglycemic effect (Review).
Iorga RA, Bacalbasa N, Carsote M, Bratu OG, et al · · 2020 · cited 63× · PMID 32765722 · DOI 10.3892/etm.2020.8714
Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach.
Overgaard RV, Lindberg SØ, Thielke D. · · 2019 · cited 25× · PMID 30047216 · DOI 10.1111/dom.13479
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

Verify or expand the search:

Other trials of semaglutide

Trials testing the same drug.

NCT07485062 — Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes · Phase 4 · not yet recruiting
NCT07523633 — Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder · Phase 2 · recruiting
NCT07466017 — A Study of CS060380 Tablets in Patients With MASH and Obesity · Phase 2 · recruiting
NCT06975111 — Focusing on the Menopausal Transition to Improve Mid-Life Women's Health · Phase 2, PHASE3 · recruiting
NCT07213466 — Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder · Phase 4 · recruiting

Other recruiting trials for Diabetes

Currently open trials in the same condition.

NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells · NA · recruiting
NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · recruiting

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 NCT02461589 (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: 31 July 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/NCT02461589.

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

NCT02461589

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (41 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of semaglutide

Other recruiting trials for Diabetes

Other Novo Nordisk A/S trials

Verify against primary sources