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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Intervention / Treatment: Drug: Placebo; Drug: MK-0941

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo/MK-0941 20mg; 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; Placebo tablets before every meal (q.a.c) Treatment period is 5 days.; Drug: MK-0941; 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.
Experimental: MK-0941 5mg/Placebo; 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; Placebo tablets before every meal (q.a.c) Treatment period is 5 days.; Drug: MK-0941; 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.
Experimental: MK-0941 5mg/MK-0941 20mg; 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; 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.
Experimental: Placebo/MK-0941 40mg; 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; Placebo tablets before every meal (q.a.c) Treatment period is 5 days.; Drug: MK-0941; 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.
Experimental: MK-0941 10mg/Placebo; 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; Placebo tablets before every meal (q.a.c) Treatment period is 5 days.; Drug: MK-0941; 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.
Experimental: MK-0941 10mg/MK-0941 40mg; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: September 16, 2008
• First Submitted That Met QC Criteria: September 16, 2008
• First Posted (Estimate): September 17, 2008

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: February 1, 2015

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: 0941-011; 2008_023 (Other Identifier: Merck Registration ID); MK-0941-011 (Other Identifier: Merck Protocol ID)