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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MK0941

• Registration Number: NCT00511667
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2012-04-04
• Results First Submitted QC: 2012-05-22
• Results First Posted: 2012-06-26
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK0941	MK0941	-

Primary Outcome Measures

Name	Time	Method
Participants With Any Clinical Adverse Experience	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	Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Secondary Outcome Measures

Name	Time	Method
Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941	Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)