NCT00094991

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started May 2004

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2007

Enrollment Period

2 years

First QC Date

October 29, 2004

Last Update Submit

September 10, 2010

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar

Interventions

MuraglitazarDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

San Antonio, Texas, 78229-3900, United States

Location

Local Institution

Pisa, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

muraglitazar

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 2004

First Posted

November 1, 2004

Study Start

May 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

September 14, 2010

Record last verified: 2007-09

Locations

IT(1)US(1)