NCT00288236

Brief Summary

Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability

Trial Health

98
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2006

Geographic Reach
12 countries

12 active sites

Status
completed

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

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1.5 years

First QC Date

February 6, 2006

Last Update Submit

April 6, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Absolute change in HbA1C from baseline to Week 48

Secondary Outcomes (1)

  • Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).

Interventions

Rimonabant (SR141716)DRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged greater than or equal to 18 years.
  • Diagnosis of type 2 diabetes as defined by WHO criteria.
  • Type 2 diabetes treated with insulin for at least 3 months (insulin dose of at least 30 U/day for at least 4 weeks).
  • HbA1C greater than or equal to 7%.
  • Having signed the informed consent form.

You may not qualify if:

  • General:
  • Weight loss \> 5 kg within 3 months prior to screening visit.
  • Pregnancy or lactation.
  • Absence of medically approved contraceptive methods for females of childbearing potential.
  • Administration of other investigational drugs within 30 days prior to screening visit.
  • Previous participation in a Rimonabant study.
  • Presence or history of allergic reaction or intolerance to multiple drugs.
  • Related to endocrine and metabolic disorders:
  • Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.
  • Fasting C-peptide \< 1.0 ng/mL.
  • Related to other disorders:
  • Presence of any severe medical or psychological condition that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
  • Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
  • Related to laboratory findings:
  • Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Buenos Aires, Argentina

Location

Sanofi-Aventis

Lane Cove, Australia

Location

Sanofi-Aventis

Laval, Canada

Location

Sanofi-Aventis

Providencia, Chile

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Berlin, Germany

Location

Sanofi-Aventis

Milan, Italy

Location

Sanofi-Aventis

Gouda, Netherlands

Location

Sanofi-Aventis

Moscow, Russia

Location

Sanofi-Aventis

Midrand, South Africa

Location

Sanofi-Aventis

Guildford, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

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

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

January 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

US(1)AR(1)CL(1)IT(1)RU(1)ZA(1)NL(1)CA(1)AU(1)FR(1)DE(1)GB(1)