A Glycemic Control Evaluation of Glimepiride Versus Rimon... | NCT00449605

ID	Type	Description	Link
2006-005385-39	EudraCT Number

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision taken in light of demands by certain national health authorities

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Mar 2009Actual

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

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

Apr 13, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 13, 2016

Certification/Extension First Posted Date

May 16, 2016Estimated

Last Update Submitted Date

Apr 13, 2016

Last Update Posted Date

May 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.

The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

Detailed Description

The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.

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

508Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rimonabant	Experimental	Rimonabant 20 mg once daily on top of metformin	Drug: Rimonabant Drug: Metformin
Glimepiride	Active Comparator	Glimepiride from 1 mg up to 6 mg once daily on top of metformin	Drug: Glimepiride Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rimonabant	Drug	Tablet, oral administration	Rimonabant	SR141716

Measure	Description	Time Frame
Change from baseline in glycemic measure HbA1c		52 weeks (1 year)

Measure	Description	Time Frame
Absolute change from baseline in body weight		52 weeks
Relative change from baseline in HDL-C		52 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with legal age
Body Mass Index >27kg/m2
Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
HbA1c >=7% and <=9% at screening visit

Exclusion Criteria:

Weight loss > 5 kg within three months prior to screening
Presence of any clinically significant endocrine disease according to the Investigator
Presence of type 1 diabetes
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
Previous participation in a clinical study with rimonabant
Absence of effective medical contraceptive method for females of childbearing potential
Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
Within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010880	Piperidines
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals