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

NCT00546325 | Completed Phase 3

• 1 other identifier: RIMON_L_01661
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

Rimonabant

Drug: Rimonabant

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Rimonabant DRUG

White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast

1

Placebo DRUG

Matching placebo tablets. Once daily before breakfast

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

North Ryde, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• David WHEATLEY

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

AU (1)