A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)

Study Overview
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Brief Summary
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A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.

Official Title
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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: MK-0941
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a BMI < 42 kg/m2 Subject is taking >1500 mg metformin per day for at least 8 weeks Subject has HbA1c value of 7.0% and < 11% at screening Subject is willing to follow AHA weight maintaining diet and exercise program Subject is a nonsmoker for at least 6 months Exclusion Criteria: Subject has type 1 diabetes Subject has a history of stroke or chronic seizure Subject has a history of neoplastic disease Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases Subject is currently taking 2 or more diabetes medications Subject has glaucoma or is blind If female, subject is pregnant or breastfeeding Subject consumes > 3 alcoholic beverages per day Subject has had major surgery or has donated blood in the last 4 weeks

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: 1<br>MK-0941 | Drug: MK-0941<br>* Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.<br>|
| Placebo Comparator: 2<br>Placebo Comparator | Drug: Comparator: Placebo<br>* Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Clinical Adverse Experience | An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0. | 2 months | 
| Number of Participants With Any Laboratory Adverse Experience | Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0. | 2 months | 
| Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration | Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24 | Baseline (predose Day 1) to Day 13 |