Clinical trial NCT00546325: REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Absolute change in HbA1c between both placebo and rimonabant group.
timeFrame: From baseline to week 48
measure: Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
timeFrame: From the beginning to the end of the study
measure: Percentage of participants responding to treatment
timeFrame: From the beginning to the end of study
measure: Rate of asymptomatic, symptomatic, and severe hypoglycaemia
timeFrame: From the beginning to the end of the study
measure: Change in physical examinations, vital signs, laboratory parameters, adverse events
timeFrame: From the beginning to the end of the study
Secondary outcomes:
measure: Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
timeFrame: From the beginning to the end of the study
measure: Change in BMI, waist and hip circumference, waist/hip ratio, weight
timeFrame: From the beginning to the end of the study
measure: Changes in Quality of Life
timeFrame: From the beginning to the end of the study
measure: Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
timeFrame: From administration of drug till end of study
measure: Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
timeFrame: From administration of drug to end of study
Other outcomes:
Locations:
city: North Ryde
country: Australia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: David WHEATLEY
role: STUDY_DIRECTOR
References: