Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00546325
First received: October 17, 2007
Last updated: December 9, 2010
Last verified: December 2010

October 17, 2007
December 9, 2010
October 2007
February 2009   (final data collection date for primary outcome measure)
  • Absolute change in HbA1c between both placebo and rimonabant group. [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: No ]
  • Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0% [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Percentage of participants responding to treatment [ Time Frame: From the beginning to the end of study ] [ Designated as safety issue: No ]
  • Rate of asymptomatic, symptomatic, and severe hypoglycaemia [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Change in physical examinations, vital signs, laboratory parameters, adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]
  • Absolute change in HbA1c between both placebo and rimonabant group. [ Time Frame: from baseline to week 48 ]
  • Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
  • Percentage of participants responding to treatment
  • Rate of asymptomatic, symptomatic, and severe hypoglycaemia
  • Change in physical examinations, vital signs, laboratory parameters, adverse events
Complete list of historical versions of study NCT00546325 on ClinicalTrials.gov Archive Site
  • Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate. [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Change in BMI, waist and hip circumference, waist/hip ratio, weight [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Changes in Quality of Life [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B) [ Time Frame: From administration of drug till end of study ] [ Designated as safety issue: No ]
  • Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio [ Time Frame: From administration of drug to end of study ] [ Designated as safety issue: No ]
  • Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
  • Change in BMI, waist and hip circumference, waist/hip ratio, weight
  • Changes in Quality of Life
  • Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
  • Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
Not Provided
Not Provided
 
REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents

Primary:

To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU).

Secondary:

To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Rimonabant
    White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
  • Drug: Placebo
    Matching placebo tablets. Once daily before breakfast
  • Experimental: 1
    Rimonabant
    Intervention: Drug: Rimonabant
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
358
February 2009
February 2009   (final data collection date for primary outcome measure)

List of Inclusion and Exclusion criteria:

Inclusion Criteria:

  • History of Type 2 diabetes
  • HbA1c between 7% to 9% (inclusive)
  • BMI ≥ 27kg/m² and BMI ≤ 40kg/m²
  • Currently taking Metformin and Sulfonylurea.

Exclusion Criteria:

  • Uncontrolled serious psychiatric illness such as major depression
  • Current use of antidepressants
  • Severe renal impairment (creatinine clearance less than 30ml/min)
  • Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase > 3 times Upper Limit Normal
  • Patient treated for epilepsy
  • Pregnant or breast-feeding women
  • Women of childbearing potential not protected by effective contraception
  • Hypersentivity/intolerance to rimonabant or any of the excipents
  • Presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety
  • Use of insulin for longer than 1 week within 4 weeks prior to screening
  • Chronic use of systemic corticosteriods
  • Use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase IV
  • History of drug or alcohol abuse wihtin the last three years
  • Heart failure class III-IV (New York Heart Association classification)
  • Severe hypertension
  • Adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies
  • Use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols
  • Use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or St John's Wort
  • Participation in a clinical study within the 4 weeks prior to randomisation
  • Patients involved in an existing weight loss program
  • Presence of chronic hepatitis
  • Use, or misuse, of substances of abuse
  • Marijuana or hashish users
  • History of gastrointestinal surgery for weight loss purposes or who are scheduled for such surgery within the duration of their expected participation in this study
  • History or presence of bulimia or laxative abuse
  • Non-English speaking

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00546325
RIMON_L_01661
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: David WHEATLEY Sanofi
Sanofi
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP