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

• ClinicalTrials.gov Identifier: NCT00325650
• Recruitment Status: Terminated
• First Posted: May 15, 2006
• Last Update Posted: May 18, 2016
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: May 12, 2006
• First Posted Date: May 15, 2006
• Last Update Posted Date: May 18, 2016
• Study Start Date: May 2006
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 19, 2016): Time of progression to type 2 diabetes [ Time Frame: Baseline to 30 months ]
• Original Primary Outcome Measures (submitted: May 12, 2006): Time of progression to type 2 diabetes

Current Secondary Outcome Measures (submitted: April 19, 2016)

• Change from baseline in body weight [ Time Frame: Baseline to 30 months ]
• Change from baseline in waist circumference [ Time Frame: Baseline to 30 months ]
• Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) [ Time Frame: Baseline to 30 months ]
• Change from baseline in glucose and insulin at 2 hour post-glucose load [ Time Frame: Baseline to 30 months ]
• Change from baseline in HDL-Cholesterol and triglycerides (TG) [ Time Frame: Baseline to 30 months ]

• Original Secondary Outcome Measures (submitted: May 12, 2006): Body weight, waist circumference, sustained effect following a washout period, HbA1C, fasting plasma glucose and 2-h post-glucose load plasma glucose, fasting insulin and 2-h post-glucose load insulin, HDL-Cholesterol and TG
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
• 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)

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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Prediabetic State

Intervention

• Drug: Rimonabant
  Tablet, oral administration
  Other Names:

  • SR141716
  • Acomplia
• Drug: Placebo (for Rimonabant)
  Tablet, oral administration

Study Arms

• Experimental: Rimonabant
  Rimonabant 20 mg once daily
  Intervention: Drug: Rimonabant
• Placebo Comparator: Placebo
  Placebo (for Rimonabant) once daily.
  Intervention: Drug: Placebo (for Rimonabant)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 12, 2009): 2420
• Original Enrollment (submitted: May 12, 2006): 2100
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00325650
• Other Study ID Numbers: EFC5107
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ICD CSD; Sanofi

• PRS Account: Sanofi
• Verification Date: April 2016