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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Rimonabant

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Rimonabant

Placebo

Outcomes

Primary Outcome Measures

Absolute change in HbA1c between both placebo and rimonabant group.

Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%

Percentage of participants responding to treatment

Rate of asymptomatic, symptomatic, and severe hypoglycaemia

Change in physical examinations, vital signs, laboratory parameters, adverse events

Secondary Outcome Measures

Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.

Change in BMI, waist and hip circumference, waist/hip ratio, weight

Changes in Quality of Life

Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)

Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio

Full Information

NCT ID

NCT00546325

First Posted

October 17, 2007

Last Updated

December 9, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00546325

Brief 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

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

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

358 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Rimonabant

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Rimonabant

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablets. Once daily before breakfast

Primary Outcome Measure Information:

Title

Absolute change in HbA1c between both placebo and rimonabant group.

Time Frame

From baseline to week 48

Title

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

Title

Percentage of participants responding to treatment

Time Frame

From the beginning to the end of study

Title

Rate of asymptomatic, symptomatic, and severe hypoglycaemia

Time Frame

From the beginning to the end of the study

Title

Change in physical examinations, vital signs, laboratory parameters, adverse events

Time Frame

From the beginning to the end of the study

Secondary Outcome Measure Information:

Title

Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.

Time Frame

From the beginning to the end of the study

Title

Change in BMI, waist and hip circumference, waist/hip ratio, weight

Time Frame

From the beginning to the end of the study

Title

Changes in Quality of Life

Time Frame

From the beginning to the end of the study

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David WHEATLEY

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

North Ryde

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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