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

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: MK0941; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Comparator: Placebo; 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
Experimental: MK0941	Drug: MK0941; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 2, 2007
• First Submitted That Met QC Criteria: August 3, 2007
• First Posted (Estimate): August 6, 2007

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0941-005; 2007_595