Study Evaluating Rimonabant Efficacy in Insulin-Treated D... | NCT00288236

Studies
Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)

NCT00288236

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 7, 2009Estimated

Enrollment

368Actual

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

Rimonabant (SR141716)
Placebo

Countries

United States
Argentina
Australia
Canada
Chile
France
Germany
Italy
Netherlands
Russia
South Africa
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Feb 6, 2006

First Submission Date that Met QC Criteria

Feb 6, 2006

First Posted Date

Feb 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2009

Last Update Posted Date

Apr 7, 2009Estimated

Description Module

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

Detailed Description

The total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 months).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

368Actual

Measure	Description	Time Frame
Absolute change in HbA1C from baseline to Week 48

Measure	Description	Time Frame
Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).

Eligibility Module

Eligibility Criteria

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.

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
Rimonabant (SR141716)	Drug
Placebo	Drug