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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00546325




Registration number
NCT00546325
Ethics application status
Date submitted
17/10/2007
Date registered
18/10/2007
Date last updated
10/12/2010

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
RIMON_L_01661
Universal Trial Number (UTN)
Trial acronym
REASSURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant
Treatment: Drugs - Placebo

Experimental: 1 - Rimonabant

Placebo Comparator: 2 - Placebo


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

Treatment: Drugs: Placebo
Matching placebo tablets. Once daily before breakfast
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in HbA1c between both placebo and rimonabant group.
Timepoint [1] 0 0
From baseline to week 48
Primary outcome [2] 0 0
Percentage of participants reaching the treat-to-target objective of HbA1c = 6.5% and = 7.0%
Timepoint [2] 0 0
From the beginning to the end of the study
Primary outcome [3] 0 0
Percentage of participants responding to treatment
Timepoint [3] 0 0
From the beginning to the end of study
Primary outcome [4] 0 0
Rate of asymptomatic, symptomatic, and severe hypoglycaemia
Timepoint [4] 0 0
From the beginning to the end of the study
Primary outcome [5] 0 0
Change in physical examinations, vital signs, laboratory parameters, adverse events
Timepoint [5] 0 0
From the beginning to the end of the study
Secondary outcome [1] 0 0
Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
Timepoint [1] 0 0
From the beginning to the end of the study
Secondary outcome [2] 0 0
Change in BMI, waist and hip circumference, waist/hip ratio, weight
Timepoint [2] 0 0
From the beginning to the end of the study
Secondary outcome [3] 0 0
Changes in Quality of Life
Timepoint [3] 0 0
From the beginning to the end of the study
Secondary outcome [4] 0 0
Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
Timepoint [4] 0 0
From administration of drug till end of study
Secondary outcome [5] 0 0
Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
Timepoint [5] 0 0
From administration of drug to end of study

Eligibility
Key inclusion criteria
List of Inclusion and
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.



- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
358
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00546325
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David WHEATLEY
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00546325