A Study to Assess the Efficacy and Tolerability of MK0478 (Muraglitazar, Also, BMS 298585) Coadministered With Insulin in Patients With Type 2 Diabetes

Merck Sharp & Dohme LLC0 sites600 target enrollmentSeptember 2005

ConditionsType 2 Diabetes Mellitus

DrugsMK0478 (muraglitazar)Comparator: placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 600
Primary Endpoint: The difference in daily dose requirements of insulin after 24 weeks
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Detailed Description

The duration of treatment is 30 weeks.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

November 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

The difference in daily dose requirements of insulin after 24 weeks

Secondary Outcomes

(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