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Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes (RAPSODI)

Primary Purpose

Prediabetic State

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rimonabant
Placebo (for Rimonabant)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetic State focused on measuring Prediabetic state, Impaired fasting glucose, Impaired glucose Tolerance

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: No previous history of treatment for type 2 diabetes. Diagnosis of : Impaired Glucose Tolerance (IGT) based on one oral glucose tolerance test (OGTT) and defined as a 2 hour post-challenge glucose (after a 75-g Oral Glucose Tolerance Test) > 140 mg/dL (7.8 mmol/L) but < 200 mg/dL (11.1 mmol/L), at the screening visit. And / or impaired fasting glucose (IFG) based on a Fasting Plasma Glucose (FPG) ³ 100 mg/dL (5.6 mmol/L) and < 126 mg/dL (7.0 mmol/L), at the screening visit. Exclusion Criteria: Absence of effective contraceptive method for females of childbearing potential. Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit. Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study. Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. Related to laboratory findings: positive test for hepatitis B surface antigen and/or hepatitis C antibody; Positive urine pregnancy test in females of childbearing potential ; Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range. Related to previous or concomitant medications: Within 3 months prior to screening visit and/or during the screening period: anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc), systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;

Sites / Locations

  • Sanofi-Aventis

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

Time of progression to type 2 diabetes

Secondary Outcome Measures

Change from baseline in body weight
Change from baseline in waist circumference
Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)
Change from baseline in glucose and insulin at 2 hour post-glucose load
Change from baseline in HDL-Cholesterol and triglycerides (TG)

Full Information

First Posted
May 12, 2006
Last Updated
April 19, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00325650
Brief Title
Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
Acronym
RAPSODI
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Both)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Company decision taken in light of demands by certain national health authorities
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary objective: To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline). Secondary objectives: To assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG), To assess the effect on quality of life To evaluate long term safety and tolerability.
Detailed Description
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Prediabetic state, Impaired fasting glucose, Impaired glucose Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2420 (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
Primary Outcome Measure Information:
Title
Time of progression to type 2 diabetes
Time Frame
Baseline to 30 months
Secondary Outcome Measure Information:
Title
Change from baseline in body weight
Time Frame
Baseline to 30 months
Title
Change from baseline in waist circumference
Time Frame
Baseline to 30 months
Title
Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)
Time Frame
Baseline to 30 months
Title
Change from baseline in glucose and insulin at 2 hour post-glucose load
Time Frame
Baseline to 30 months
Title
Change from baseline in HDL-Cholesterol and triglycerides (TG)
Time Frame
Baseline to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: No previous history of treatment for type 2 diabetes. Diagnosis of : Impaired Glucose Tolerance (IGT) based on one oral glucose tolerance test (OGTT) and defined as a 2 hour post-challenge glucose (after a 75-g Oral Glucose Tolerance Test) > 140 mg/dL (7.8 mmol/L) but < 200 mg/dL (11.1 mmol/L), at the screening visit. And / or impaired fasting glucose (IFG) based on a Fasting Plasma Glucose (FPG) ³ 100 mg/dL (5.6 mmol/L) and < 126 mg/dL (7.0 mmol/L), at the screening visit. Exclusion Criteria: Absence of effective contraceptive method for females of childbearing potential. Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit. Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study. Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. Related to laboratory findings: positive test for hepatitis B surface antigen and/or hepatitis C antibody; Positive urine pregnancy test in females of childbearing potential ; Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range. Related to previous or concomitant medications: Within 3 months prior to screening visit and/or during the screening period: anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc), systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;
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
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

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Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

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