REASSURE
REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
Sponsor study identifier
interventional
358
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
February 2009
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 17, 2007
Actual (reported)October 18, 2007
Actual (reported)February 2009
Actual (reported)February 2009
Actual (reported)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
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
Rimonabant
Placebo
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
Matching placebo tablets. Once daily before breakfast
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sanofi-Aventis Administrative Office
North Ryde, Australia
David WHEATLEY
Sanofi
358 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2007
First Posted
October 18, 2007
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2009
Actual (reported)Study Completion
February 2009
Actual (reported)Last Updated
December 10, 2010
Record last verified: 2010-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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