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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK0941; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511667

2007_595

0941-005

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

MK0941

Experimental group

Treatment:

Drug: MK0941

Placebo

Placebo Comparator group

Treatment:

Drug: Comparator: Placebo