A clinical study to evaluate the effects of GLP-1 agonist AVE0010 in paTients with type 2 diabetes mellitus for Glycemic cOntrol and sAfety evaLuation, on top of Sulfonylurea

A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of a sulfonylurea in patients with type 2 diabetes not adequately controlled with sulfonylurea. - GETGOAL-S

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000176

Enrollment

855

Registered

2008-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes for Glycemic Control and Safety Evaluation Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: AVE0010: Two Step Arm:-10&amp

#956

(1stweek) -15&amp

g(2ndweek) -20&amp

g(for remaining 22 weeks) Control Intervention1: Volume Matched Placebo: 0.10mL - 1st week. 0.15mL - 2nd Week. 0.20mL - remaining 22 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: - Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with a sulfonylurea alone or a sulfonylurea in association with metformin

Exclusion criteria

Exclusion criteria: -HbA1c < 7% or > 10% -Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method -Sulfonylurea not at a stable (unchanged) dose for at least 3 months prior to screening and less than the maximal effective dose according to local labeling -Body mass index < 20 kg/m2 -Weight change of more than 5 kg during the 3 months preceding the study, -Participation in any previous study with AVE0010 -Use of any investigational drug within 3 months prior to study

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in HbA1cTimepoint: Time Frame: 24 weeks	—

Secondary

Measure	Time frame
(1)Change from baseline in body weight. (2)Change from baseline in fasting plasma glucose (3)Change from baseline in 2-hours post-prandial plasma glucose, glucagon, insulin, pro-insulin, C-peptideTimepoint: (1) Time Frame: 24 weeks. (2) Time Frame: 24 weeks (3) Time Frame: 24 weeks , Respectiveli	—

Countries

Bulgaria, Czech Republic, Egypt, Germany, India, Israel, Japan, Netherlands, Republic of Korea, Romania, Russian Federation, Taiwan, Thailand, Tunisia, Turkey, United States of America

Contacts

Public ContactMs Vaishali Kanade

Sanofi-Synthelabo (India) Limited

vaishali.kanade@sanofi-aventis.com02230707823

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026