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

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-001613-17-IT
• Date of registration: 30/08/2006
• Prospective Registration: No
• Primary sponsor: Sanofi-Synthelabo Recherche
• Public 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 - ARPEGGIO
• Scientific 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 - ARPEGGIO
• Date of first enrolment: 12/01/2006
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001613-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Male or female patients aged or equal to 18 years Type 2 diabetes as defined by WHO criteria fasting venous plasma glucose concentration or equal to 7.0 mmol/L or 2-h post-glucose load venous plasma glucose or equal to 11.1 mmol/L treated with insulin any type and regimen for at least three months insulin dose or equal to 30 U/day for at least 4 weeks with HbA1c or equal to 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 g 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetic Patients Inadequately Controlled with Insulin
MedDRA version: 6.1 Level: PT Classification code 10012607

Intervention(s)

Product Name: rimonabant
Product Code: SR141716
Pharmaceutical Form: Tablet
CAS Number: 168273-06-1
Current Sponsor code: SR141716
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the effect of rimonabant on HbA1c in patients with type 2 diabetes treated with insulin.

Secondary Objective: To assess the effect of rimonabant in patients with type 2 diabetes treated with insulin -on body weight -on lipid profile -on abdominal obesity; to assess the safety and tolerability of rimonabant in patients with type 2 diabetes treated with insulin

Primary end point(s): The primary efficacy endpoint is to evaluate HbA1c in type II diabetic patients treated with insulin

Secondary ID(s)

2005-001613-17-GB

EFC5593 -ARPEGGIO