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 - ARPEGGIO

Phase 1

• Conditions: Type 2 Diabetic Patients Inadequately Controlled with Insulin; MedDRA version: 8.0 Level: LLT Classification code 10063624

• Registration Number: EUCTR2005-001613-17-GB
• Lead Sponsor: sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-10
• Study Completion: 2007-07-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

• Male or female patients aged = 18 years
• Type 2 diabetes as defined by WHO criteria (fasting venous plasma glucose
concentration = 7.0 mmol/L or 2-h post-glucose load venous plasma glucose = 11.1
mmol/L) treated with insulin (any type and regimen) for at least three months (insulin
dose = 30 U/day for at least 4 weeks) with HbA1c = 7% at screening Visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Presence of any clinically significant endocrine disease according to the Investigator
(euthyroid patients on replacement therapy will be included if the dosage of thyroxine
is stable for at least three months prior to screening visit)
• Presence of type 1 diabetes (C-peptide < 1.0 ng/mL)
• Presence of any clinically significant condition that might interfere with the evaluation of study medication
• Presence or history of cancer within the past five years with the exception of
adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
• Laboratory abnormalities including:
- C-peptide < 1.0 ng/mL
- positive urine pregnancy test in females of childbearing potential at screening visit
- abnormal serum thyrotropin (TSH) levels at screening visit
- positive test for hepatitis B surface antigen and/or hepatitis C antibody at screening
visit
- any relevant abnormality interfering with the efficacy or the safety assessments
during the study drug administration
• Some medications:
- administration of antidiabetic drugs other than insulin within three months prior to
screening visit
- administration of anti-obesity drugs (sibutramine, orlistat) or other drugs for
weight reduction (e.g., phentermine, amphetamines) within three months prior to
screening visit or administration of herbal preparations for weight reduction
within 30 days prior to screening visit
- administration of thyroid preparations or thyroxine (except in patients on stable
replacement therapy) within three months prior to screening visit
- administration of systemic long-acting corticosteroids within two months or
prolonged use (more than one week) of other systemic corticosteroids or inhaled
corticosteroids (if daily dosage is > 1,000 µg equivalent beclomethasone) within
30 days prior to screening visit
- change in the treatment of dyslipidemia within two months prior to screening visit
or between screening and baseline visits
• Pregnancy or breast-feeding
• Absence of effective contraceptive methods for females of childbearing potential

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified