NCT00478972

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 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

May 24, 2007

Last Update Submit

June 6, 2016

Conditions

ObesityDiabetes Mellitus Type 2

Keywords

obesediabetescannabinoid-1 receptor

Outcome Measures

Primary Outcomes (2)

  • Absolute change from baseline in HbA1C

    Baseline to Week 36

  • Relative change from baseline in body weight

    Baseline to Week 36

Secondary Outcomes (4)

  • Absolute change from baseline in Fasting Plasma Glucose

    Baseline to Week 36

  • Absolute change from baseline in waist circumference

    Baseline to Week 36

  • Relative change from baseline in Triglycerides and HDL-cholesterol

    Baseline to Week 36

  • Safety: Overview of adverse events

    Baseline to Week 47

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily in addition to diet and exercise

Drug: RimonabantOther: Diet and exercise

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily in addition to diet and exercise

Drug: placebo (for Rimonabant)Other: Diet and exercise

Interventions

RimonabantDRUG

Tablet, oral administration

Also known as: SR141716, Acomplia
Rimonabant
placebo (for Rimonabant)DRUG

Tablet, oral administration

Placebo
Diet and exerciseOTHER

Target daily caloric intake: Ideal body weight × 25 kcal

PlaceboRimonabant

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

RimonabantDietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidinesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • ICD CSD

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

April 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations

JP(1)