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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 25 November 2019
Main ID:  EUCTR2005-001613-17-GB
Date of registration: 10/11/2005
Prospective Registration: Yes
Primary sponsor: sanofi-aventis recherche et développement
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: 27/02/2006
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
 
Phase:  Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV):
Countries of recruitment
Germany Italy United Kingdom
Contacts
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Affiliation: 
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Key inclusion & exclusion criteria
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


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: 8.0 Level: LLT Classification code 10063624
Intervention(s)

Product Name: Rimonabant
Product Code: SR141716
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rimonabant
CAS Number: 168273-06-1
Current Sponsor code: SR141716 Form 2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated 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.
Secondary Outcome(s)
Secondary ID(s)
CPR-EFC5593-EN-E01
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 30/04/2016
Date Completed: 20/07/2007
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-001613-17/results
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