Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

NCT00325650 | Terminated Phase 3 DMC

• 1 other identifier: EFC5107
• Study Type: interventional
• Target: 2,420
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State

Keywords

Prediabetic state; Impaired fasting glucose; Impaired glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• Time of progression to type 2 diabetes

  Baseline to 30 months

Secondary Outcomes (5)

• Change from baseline in body weight

  Baseline to 30 months

• Change from baseline in waist circumference

  Baseline to 30 months

• Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)

  Baseline to 30 months

• Change from baseline in glucose and insulin at 2 hour post-glucose load

  Baseline to 30 months

• Change from baseline in HDL-Cholesterol and triglycerides (TG)

  Baseline to 30 months

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily

Drug: Rimonabant

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily.

Drug: Placebo (for Rimonabant)

Interventions

Rimonabant DRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

Placebo (for Rimonabant) DRUG

Tablet, oral administration

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 15, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 18, 2016

Record last verified: 2016-04

Locations

US (1)