An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	Merck Bristol-Myers Squibb
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00130806

Purpose

This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0478 (muraglitazar) Drug: Comparator: placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Muraglitazar

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Assess the Efficacy and Tolerability of MK-0478 (Muraglitazar, Also, BMS 298585) Coadministered With Insulin in Patients With Type 2 Diabetes

Further study details as provided by Merck:

Primary Outcome Measures:

The difference in daily dose requirements of insulin after 24 weeks

Secondary Outcome Measures:

(a) HbA1C; (b) FPG; (c) Percent of patients with HbA1C <7.0%; (d) TG, HDL-C, non-HDL-C and apolipoprotein B; (e) Free Fatty Acids (FFA); (f) the incidence of hypoglycemic events at 24 weeks

Estimated Enrollment:	600
Study Start Date:	October 2005

Detailed Description:

The duration of treatment is 30 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.)

Exclusion Criteria:

People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130806

Show 66 Study Locations

Sponsors and Collaborators

Merck

Bristol-Myers Squibb

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2005_020
Study First Received:	August 12, 2005
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00130806
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009