Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00288236




Registration number
NCT00288236
Ethics application status
Date submitted
6/02/2006
Date registered
7/02/2006
Date last updated
7/04/2009

Titles & IDs
Public title
Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(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
Secondary ID [1] 0 0
EFC5593
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in HbA1C from baseline to Week 48
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
368
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Lane Cove
Recruitment postcode(s) [1] 0 0
- Lane Cove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
Chile
State/province [4] 0 0
Providencia
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
Netherlands
State/province [8] 0 0
Gouda
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Moscow
Country [10] 0 0
South Africa
State/province [10] 0 0
Midrand
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00288236