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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: Placebo; Drug: MK-0941

• Registration Number: NCT00754130
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-17
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2012-08-31
• Results First Submitted QC: 2012-08-31
• Results First Posted: 2012-10-03
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0941 10mg/Placebo	MK-0941	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.
MK-0941 10mg/MK-0941 40mg	MK-0941	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.
Placebo/MK-0941 20mg	Placebo	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.
Placebo/MK-0941 20mg	MK-0941	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.
Placebo/MK-0941 40mg	MK-0941	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.
MK-0941 10mg/Placebo	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.
MK-0941 5mg/Placebo	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.
MK-0941 5mg/Placebo	MK-0941	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.
MK-0941 5mg/MK-0941 20mg	MK-0941	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.
Placebo/MK-0941 40mg	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Adverse Event (AE)	Up to 14 days after last dose of study drug	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.
Number of Participants Who Discontinued Study Drug Due to an AE	Up to 14 days after last dose of study drug	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.

Secondary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941	Up to 72 hours after study drug administration	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.
Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941	Up to 72 hours after study drug administration	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.
Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941	Up to 72 hours after study drug administration	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.
Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr	Day 5 and Day 1	Geometric Mean of the Day 5 to Day 1 Accumulation Ratio
Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941	Up to 72 hours after study drug administration	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.
Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)	Up to 72 hours after study drug administration	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.