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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00546325

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Rimonabant Drug: Placebo	Phase IV

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Rimonabant SR 141716A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	382
Study Start Date:	October 2007
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rimonabant	Drug: Rimonabant White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
2: Placebo Comparator Placebo	Drug: Placebo Matching placebo tablets. Once daily before breakfast

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546325

Locations

Australia
Sanofi-Aventis
North Ryde, Australia

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

David WHEATLEY

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	RIMON_L_01661
Study First Received:	October 17, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00546325
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Overweight
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009