A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20mg) multicenter study of long-term glycemic control with rimonabantin treatment-naïve patients with type 2 diabetes - SERENADE

Phase 1

• Conditions: Patients with Type 2 diabetes not treated by a pharmacological agent.; MedDRA version: 7.0Level: LLTClassification code 10045242

• Registration Number: EUCTR2004-004881-34-GB
• Lead Sponsor: Sanofi-Synthelabo Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Study Completion: 2006-06-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Male or female patients aged = 18 years.
• Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months
but no longer than 3 years.
• Type 2 diabetes not previously treated by a pharmacological agent.
• HbA1C = 7% and = 10%.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Weight loss > 5 kg within 3 months prior to screening visit.
• Pregnancy or lactation.
• Absence of medically approved contraceptive methods for females of childbearing potential.
• Marijuana or hashish users.
• Presence or history of allergic reaction or intolerance to multiple drugs.
• Presence of any other condition (e.g. geographic, social …) actual or anticipated,
that the Investigator feels that would restrict or limit the patient’s participation for
the duration of the study.
• No use of any oral antidiabetic agent is allowed prior to the entry of the study, except for the conditions described in the protocol.
• No use of insulin is allowed prior to the entry of the study, except for the conditions described in the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first primary objective is to assess the antidiabetic effect of rimonabant (HbA1C) over a period of 6 months when prescribed in treatment-naïve type 2 diabetes patients.;Secondary Objective: • To assess the effect of rimonabant over a period of 6 months on :<br>- other markers of glycemic control (fasting glucose, fasting-insulin and C-peptide) and on insulin resistance/insulin sensitivity and ß-cell function (HOMA indices);<br>- Body weight.<br>- other risk factors (HDL-Cholesterol, TG, blood pressure).<br><br>• To evaluate the safety and tolerability of rimonabant over a period of 6 months in this treatment naïve population.;Primary end point(s): The primary endpoint is the absolute change in HbA1C from baseline to Month 6.