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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MK0941
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK0941<br> | Drug: MK0941<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: Comparator: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |