An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)

Phase 3TerminatedNCT00130806

Merck Sharp & Dohme LLC600 enrolled

Overview

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.

The duration of treatment is 30 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Type 2 Diabetes Mellitus

Interventions

MK0478 (muraglitazar)DRUG

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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