Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2265
Source ID: NCT00546325
Associated Drug: Rimonabant
Title: REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
Acronym: REASSURE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Rimonabant|DRUG: Placebo
Outcome Measures: Primary: Absolute change in HbA1c between both placebo and rimonabant group., From baseline to week 48|Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%, From the beginning to the end of the study|Percentage of participants responding to treatment, From the beginning to the end of study|Rate of asymptomatic, symptomatic, and severe hypoglycaemia, From the beginning to the end of the study|Change in physical examinations, vital signs, laboratory parameters, adverse events, From the beginning to the end of the study | Secondary: Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate., From the beginning to the end of the study|Change in BMI, waist and hip circumference, waist/hip ratio, weight, From the beginning to the end of the study|Changes in Quality of Life, From the beginning to the end of the study|Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B), From administration of drug till end of study|Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio, From administration of drug to end of study
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 358
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-10
Completion Date: 2009-02
Results First Posted:
Last Update Posted: 2010-12-10
Locations: Sanofi-Aventis Administrative Office, North Ryde, Australia
URL: https://clinicaltrials.gov/show/NCT00546325