A clinical trial to study the efficacy and safety of AVE0010 in patients with type 2 diabetes not treated with antidiabetic agents

A randomized, double-blind, placebo-controlled, parallel-group, multicenter 12-week study assessing the efficacy and safety of AVE0010 in patients with type 2 diabetes not treated with antidiabetic agents - GETGOAL MONO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000071

Enrollment

361

Registered

2008-07-15

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: E116- Type 2 diabetes mellitus with other specified complications

Interventions

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

#956

g(1stweek) -15&amp

g(2ndweek) -20&amp

g(for remaining 10 weeks) One Step arm:- -10&amp

g for the 1st 2 weeks. -20&amp

g for the remaining 10 weeks. Control Intervention1: Volume-matched placebo: Two step arm: 10 &#956

g for the 1st week 15 &#956

g for the 2nd week 20 &#956

g for the remaining 10 weeks One step arm: 10 &#956

g for the 1st 2 weeks 20 &#956

g for the remaining 10 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus not treated with any antidiabetic agent

Exclusion criteria

Exclusion criteria: (1) HbA1c < 7% or > 10% (2) Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control (3) Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study (4) Body mass index < 20 kg/m2 (5) Weight change of more than 5 kg during the 3 months preceding the study. (6) Participation in any previous study with AVE0010 (7) Use of any investigational drug within 3 months prior to study

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in HbA1cTimepoint: 12 Weeks	—

Secondary

Measure	Time frame
Change from baseline in 2-hours post-prandial plasma glucoseTimepoint: 12 Weeks;Change from baseline in body weightTimepoint: 12 Weeks;Change from baseline in fasting plasma glucoseTimepoint: 12 Weeks	—

Countries

Belgium, India, Israel, Japan, Mexico, Poland, Republic of Korea, Romania, Russian Federation, Tunisia, United States of America

Contacts

Public ContactVaishali Kanade

Sanofi-Synthelabo (India) Limited

vaishali.kanade@sanofi-aventis.com02230707823

Outcome results

None listed

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