A Glycemic Control Evaluation of Glimepiride versus Rimonabant on Top of Metformin in Type 2 Diabetes

A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control with Rimonabant in Comparison with Glimepiride over 1 Year in Overweight/Obese Type 2 Diabetic Patients Not Adequately Controlled with Metformin - ALLEGRO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000040

Enrollment

500

Registered

2008-04-24

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 Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Rimonabant: 20mg / day for 52 weeks Control Intervention1: Glimepiride: Dose adjustment for initial 12 weeks with 1mg , 2mg &amp

4mg Glimepiride. Thereafter maintenance period with adjusted dose based on forced dose titration period

Eligibility

Inclusion criteria

Inclusion criteria: ? Patients with legal age ? Body Mass Index >27kg/m2 ? Type 2 diabetes as defined by WHO criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three

Exclusion criteria

Exclusion criteria: ? Weight loss > 5 kg within three months prior to screening ? Presence of any clinically significant endocrine disease according to the Investigator ? Presence of type 1 diabetes ? Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer ? Previous participation in a clinical study with rimonabant ? Absence of effective medical contraceptive method for females of childbearing potential ? Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction ? Within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment

Design outcomes

Primary

Measure	Time frame
Change in Glycemic measure HbA1cTimepoint: baseline to 52 weeks (1 year	—

Secondary

Measure	Time frame
Absolute change in body weightTimepoint: from baseline to 1 year and relative change in HDL-Cholesterol from baseline to 1 year	—

Countries

Democratic People's Republic of Korea, India

Contacts

Public ContactDr Chirag Trivedi

Sanofi-Synthelabo (India) Limited

chirag.trivedi@sanofi.com02230707821

Outcome results

None listed

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