Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)

Phase 2TerminatedNCT00543959

Merck Sharp & Dohme LLC346 enrolled

Overview

A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

346

Conditions

Diabetes Mellitus Type 2

Interventions

MK0533DRUG

Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

Comparator: Placebo (unspecified)DRUG

MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.

Comparator: pioglitazoneDRUG

pioglitazone 45mg. Study period is a total of 24 wks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels * Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened Exclusion Criteria: * Patients taking any medicines that affect body fluid level such as a diuretic or water pill * Patients taking niacin or other certain medications * Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders * Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study

Outcomes

Primary Outcomes

Body fluid gain from baseline after 12 weeks

Time frame: 12 weeks

Secondary Outcomes

Fasting plasma glucose after 12 weeks

Time frame: 12 weeks

Data from ClinicalTrials.gov

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