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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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
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Secondary ID [1]
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EFC5593
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant (SR141716)
Treatment: Drugs - Placebo
Treatment: Drugs: Rimonabant (SR141716)
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute change in HbA1C from baseline to Week 48
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).
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Assessment method [1]
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Timepoint [1]
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2007
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Sample size
Target
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Accrual to date
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Final
368
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis - Lane Cove
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Recruitment postcode(s) [1]
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- Lane Cove
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Country [2]
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Argentina
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State/province [2]
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Buenos Aires
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Canada
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State/province [3]
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Laval
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Country [4]
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Chile
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State/province [4]
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Providencia
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Country [5]
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France
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State/province [5]
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Paris
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Country [6]
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Germany
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State/province [6]
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Berlin
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Country [7]
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Italy
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State/province [7]
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Milano
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Country [8]
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Netherlands
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State/province [8]
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Gouda
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Country [9]
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Russian Federation
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State/province [9]
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Moscow
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Country [10]
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South Africa
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State/province [10]
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Midrand
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Country [11]
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United Kingdom
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State/province [11]
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Guildford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00288236
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ICD CSD
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00288236
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