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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Rimonabant (SR141716)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No