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

Primary Purpose

Obesity, Diabetes Mellitus Type 2

Status

Terminated

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Rimonabant

Placebo (for Rimonabant)

Anti-diabetic monotherapy

About this trial

This is an interventional treatment trial for Obesity focused on measuring obese, diabetes, cannabinoid-1 receptor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rimonabant

Placebo

Arm Description

Rimonabant 20 mg once daily

Placebo (for Rimonabant) once daily

Outcomes

Primary Outcome Measures

Absolute change from baseline in HbA1C

Relative change from baseline in in body weight

Secondary Outcome Measures

Absolute change from baseline in Fasting Plasma Glucose

Absolute change from baseline in waist circumference

Relative change from baseline in Triglycerides and HDL-cholesterol

Safety: overview of adverse events

Full Information

NCT ID

NCT00478595

First Posted

May 24, 2007

Last Updated

June 1, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00478595

Brief Title

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

Acronym

SYMPHONY

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 Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Company decision taken in light of demands by certain national health authorities

Study Start Date

April 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Diabetes Mellitus Type 2

Keywords

obese, diabetes, cannabinoid-1 receptor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

458 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rimonabant

Arm Type

Experimental

Arm Description

Rimonabant 20 mg once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (for Rimonabant) once daily

Intervention Type

Drug

Intervention Name(s)

Rimonabant

Other Intervention Name(s)

SR141716, Acomplia

Intervention Description

Tablet, oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo (for Rimonabant)

Intervention Description

Tablet, oral administration

Intervention Type

Drug

Intervention Name(s)

Anti-diabetic monotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Absolute change from baseline in HbA1C

Time Frame

Baseline to week 52

Title

Relative change from baseline in in body weight

Time Frame

Baseline to week 52

Secondary Outcome Measure Information:

Title

Absolute change from baseline in Fasting Plasma Glucose

Time Frame

Baseline to week 52

Title

Absolute change from baseline in waist circumference

Time Frame

Baseline to week 52

Title

Relative change from baseline in Triglycerides and HDL-cholesterol

Time Frame

Baseline to week 52

Title

Safety: overview of adverse events

Time Frame

Baseline to Week 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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