SYMPHONY: Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00478595

Collaborator

(none)

458

Enrollment

Location

Arms

22.1

Duration (Months)

20.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).

The secondary objectives are:

To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
To evaluate the safety and tolerability of Rimonabant compared to placebo;
To evaluate the pharmacokinetics of Rimonabant.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus Type 2	Drug: Rimonabant Drug: Placebo (for Rimonabant) Drug: Anti-diabetic monotherapy	Phase 3

Detailed Description

The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.

Study Design

Study Type:

Interventional

Actual Enrollment :

458 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients on Monotherapy Inadequately Controlled With Oral Anti-diabetic Drug

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rimonabant Rimonabant 20 mg once daily	Drug: Rimonabant Tablet, oral administration Other Names: SR141716 Acomplia Drug: Anti-diabetic monotherapy Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
Placebo Comparator: Placebo Placebo (for Rimonabant) once daily	Drug: Placebo (for Rimonabant) Tablet, oral administration Drug: Anti-diabetic monotherapy Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period

Arm

Intervention/Treatment

Experimental: Rimonabant

Rimonabant 20 mg once daily

Drug: Rimonabant

Tablet, oral administration

Other Names:

SR141716

Acomplia

Drug: Anti-diabetic monotherapy

Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period

Placebo Comparator: Placebo

Placebo (for Rimonabant) once daily

Drug: Placebo (for Rimonabant)

Tablet, oral administration

Drug: Anti-diabetic monotherapy

Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period

Outcome Measures

Primary Outcome Measures

Absolute change from baseline in HbA1C [Baseline to week 52]
Relative change from baseline in in body weight [Baseline to week 52]

Secondary Outcome Measures

Absolute change from baseline in Fasting Plasma Glucose [Baseline to week 52]
Absolute change from baseline in waist circumference [Baseline to week 52]
Relative change from baseline in Triglycerides and HDL-cholesterol [Baseline to week 52]
Safety: overview of adverse events [Baseline to Week 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)
HbA1C ≥ 7.0 % and ≤ 10.0 %
Body Mass Index ≥ 25 kg/m²

Exclusion Criteria:

Type 1 diabetes
Within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
Within 4 weeks 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
Secondary obesity
Primary hyperlipidemia
Positive serum pregnancy test in females of childbearing potential