Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00478972

Purpose

The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.

The secondary objectives are:

To evaluate the effect of SR141716 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 SR141716 compared to placebo
To evaluate the pharmacokinetics of SR141716

Condition	Intervention	Phase
Obesity Diabetes Mellitus Type 2	Drug: rimonabant (SR141716) Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness Obesity

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Absolute change in HbA1C from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
Relative change in body weight from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change, in Fasting Plasma Glucose and in waist circumference from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
Relative change in Triglycerides and HDL-cholesterol from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
Safety: adverse events, laboratory tests, vital signs [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Enrollment:	321
Study Start Date:	May 2007
Study Completion Date:	January 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rimonabant (SR141716) oral administration
2: Placebo Comparator	Drug: placebo oral administration

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478972

Locations

Japan
Sanofi-aventis Administrative Office
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6648
Study First Received:	May 24, 2007
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00478972 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

obese
diabetes
cannabinoid-1 receptor

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010