Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

NCT00478595 | Terminated Phase 3

• 1 other identifier: EFC6647
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor). The secondary objectives are:

• To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
• To evaluate the safety and tolerability of Rimonabant compared to placebo;
• To evaluate the pharmacokinetics of Rimonabant.

Conditions

Obesity; Diabetes Mellitus Type 2

Keywords

obese; diabetes; cannabinoid-1 receptor

Outcome Measures

Primary Outcomes (2)

• Absolute change from baseline in HbA1C

  Baseline to week 52

• Relative change from baseline in in body weight

  Baseline to week 52

Secondary Outcomes (4)

• Absolute change from baseline in Fasting Plasma Glucose

  Baseline to week 52

• Absolute change from baseline in waist circumference

  Baseline to week 52

• Relative change from baseline in Triglycerides and HDL-cholesterol

  Baseline to week 52

• Safety: overview of adverse events

  Baseline to Week 56

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily

Drug: Rimonabant; Drug: Anti-diabetic monotherapy

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily

Drug: Placebo (for Rimonabant); Drug: Anti-diabetic monotherapy

Interventions

Rimonabant DRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

Placebo (for Rimonabant) DRUG

Tablet, oral administration

Placebo

Anti-diabetic monotherapy DRUG

Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period

Placebo; Rimonabant

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)
• HbA1C ≥ 7.0 % and ≤ 10.0 %
• Body Mass Index ≥ 25 kg/m²

You may not qualify if:

• Type 1 diabetes
• Within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
• Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
• Secondary obesity
• Primary hyperlipidemia
• Positive serum pregnancy test in females of childbearing potential
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 25, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

JP (1)