A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)

Merck Sharp & Dohme LLC70 enrolled

Overview

A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

MK0941DRUG

MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Comparator: PlaceboDRUG

Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Nonsmoking Male or Female (of non-child bearing potential) * Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents * Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more Exclusion Criteria: * Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist * Subject is on 3 or more oral anti-diabetes medications * Subject has a history of type 1 diabetes * Subject has a diagnosis of glaucoma or is blind * Subject has had trauma to one or both eyes

Outcomes

Primary Outcomes

Participants With Any Clinical Adverse Experience

Time frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Participants Discontinued Because of Any Clinical Adverse Experience

Time frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)