MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).

Study Overview
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Brief Summary
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The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.

Official Title
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A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese Male or Female between 20 to 65 years of age Diagnosis of Type 2 Diabetes Patient being treated by diet and exercise alone Exclusion Criteria: Patient has a history of Type 1 Diabetes Patient is being treated with glaucoma medications Patient has donated blood or participated in another clinical study in the past 12 weeks Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Placebo/MK-0941 20mg<br>Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. | Drug: Placebo<br>* Placebo tablets before every meal (q.a.c) Treatment period is 5 days.<br>Drug: MK-0941<br>* MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.<br>|
| Experimental: MK-0941 5mg/Placebo<br>Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. | Drug: Placebo<br>* Placebo tablets before every meal (q.a.c) Treatment period is 5 days.<br>Drug: MK-0941<br>* MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.<br>|
| Experimental: MK-0941 5mg/MK-0941 20mg<br>Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. | Drug: MK-0941<br>* MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.<br>|
| Experimental: Placebo/MK-0941 40mg<br>Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. | Drug: Placebo<br>* Placebo tablets before every meal (q.a.c) Treatment period is 5 days.<br>Drug: MK-0941<br>* MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.<br>|
| Experimental: MK-0941 10mg/Placebo<br>Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. | Drug: Placebo<br>* Placebo tablets before every meal (q.a.c) Treatment period is 5 days.<br>Drug: MK-0941<br>* MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.<br>|
| Experimental: MK-0941 10mg/MK-0941 40mg<br>Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. | Drug: MK-0941<br>* MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2. | Up to 14 days after last dose of study drug | 
| Number of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2. | Up to 14 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration | 
| Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration | 
| Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration | 
| Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration | 
| Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration | 
| Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr | Geometric Mean of the Day 5 to Day 1 Accumulation Ratio | Day 5 and Day 1 |