NCT01940965 is a Phase 3 clinical trial of lixisenatide AVE0010 in Type 2 Diabetes Mellitus, sponsored by Sanofi.

Who is sponsoring NCT01940965?

NCT01940965 is sponsored by Sanofi.

What drugs are being tested in NCT01940965?

Interventions in NCT01940965: lixisenatide AVE0010, biguanide, TZD, alpha-GI, glinide.

What condition does NCT01940965 study?

NCT01940965 studies Type 2 Diabetes Mellitus.

Is NCT01940965 still recruiting?

NCT01940965 is currently completed. Last updated 3 August 2015.

Last reviewed 2015-08-03 · How we verify

NCT01940965

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

An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Completed Phase 3 Last updated 3 August 2015

What this trial tests

Phase 3 trial testing lixisenatide AVE0010 in Type 2 Diabetes Mellitus in 294 participants. Completed in 1 July 2015.

Timeline

1 September 2013

Primary endpoint
1 July 2015

1 July 2015

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	294
Start date	1 September 2013
Primary completion	1 July 2015
Estimated completion	1 July 2015
Sites	27 locations across Japan

Drugs / interventions tested

lixisenatide AVE0010
biguanide — full drug profile →
TZD — full drug profile →
alpha-GI — full drug profile →
glinide — full drug profile →

Conditions studied

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

Sponsor

Sanofi — full company profile →

Who can join

20 and older, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data
Time frame: 52 weeks

Sponsor's own description

Primary Objective: The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan. Secondary Objective: To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on: * HbA1c; * Fasting plasma glucose; * Body weight.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.
Seino Y, Stjepanovic A, Takami A, Takagi H, et al · · 2018 · cited 4× · PMID 28429860 · DOI 10.1111/jdi.12686

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · 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 NCT01940965 (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 Sanofi
Last refreshed: 3 August 2015

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/NCT01940965.

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