Mechanism of Action and Efficacy of Muraglitazar in Type... | NCT00094991

Studies
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

NCT00094991

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Sep 14, 2010Estimated

Enrollment

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Muraglitazar

Countries

United States
Italy

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2004

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Oct 29, 2004

First Submission Date that Met QC Criteria

Oct 29, 2004

First Posted Date

Nov 1, 2004Estimated

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

Sep 10, 2010

Certification/Extension First Submitted that Passed QC Review

Sep 10, 2010

Certification/Extension First Posted Date

Sep 14, 2010Estimated

Last Update Submitted Date

Sep 10, 2010

Last Update Posted Date

Sep 14, 2010Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to learn more about how muraglitazar lowers blood sugar in people with type 2 diabetes. The safety of this treatment will also be studied.

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Muraglitazar	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes;
Serum triglyceride concentration < or = 600 mg/dL;
Body mass index < or = 37 kg/m2

Exclusion Criteria:

Type 1 diabetes;
History of myocardial infarction (MI), coronary angioplasty, bypass graft(s), valvular disease, unstable angina pectoris, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within 6 months;
Congestive heart failure (NYHA Class III and IV);
Uncontrolled hypertension;
Women of Child Bearing Potential
History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease, or endocrine disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		San Antonio	Texas	78229-3900	United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C500085	muraglitazar

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided