Clinical trial NCT00288236: Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Absolute change in HbA1C from baseline to Week 48
Secondary outcomes:
measure: Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis
city: Lane Cove
country: Australia
facility: Sanofi-Aventis
city: Laval
country: Canada
facility: Sanofi-Aventis
city: Providencia
country: Chile
facility: Sanofi-Aventis
city: Paris
country: France
facility: Sanofi-Aventis
city: Berlin
country: Germany
facility: Sanofi-Aventis
city: Milano
country: Italy
facility: Sanofi-Aventis
city: Gouda
country: Netherlands
facility: Sanofi-Aventis
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
city: Midrand
country: South Africa
facility: Sanofi-Aventis
city: Guildford
country: United Kingdom
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: