Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/Day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled With Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288236
• Other study ID #: EFC5593
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2006
• Last updated: April 6, 2009
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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

Description:

The total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

• Abnormal TSH level (TSH > ULN or < LLN).

• Positive urine pregnancy test.

Related to previous or concomitant medications:

• Antidiabetic drugs other than insulin within 3 months prior to screening visit.

• Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Rimonabant (SR141716)

• Placebo

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	Buenos Aires
Australia	Sanofi-Aventis	Lane Cove
Canada	Sanofi-Aventis	Laval
Chile	Sanofi-Aventis	Providencia
France	Sanofi-Aventis	Paris
Germany	Sanofi-Aventis	Berlin
Italy	Sanofi-Aventis	Milano
Netherlands	Sanofi-Aventis	Gouda
Russian Federation	Sanofi-Aventis	Moscow
South Africa	Sanofi-Aventis	Midrand
United Kingdom	Sanofi-Aventis	Guildford
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  France,  Germany,  Italy,  Netherlands,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in HbA1C from baseline to Week 48
Secondary	Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).