NCT00754130 - MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011). | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

16

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

PlaceboDRUG

Placebo tablets before every meal (q.a.c) Treatment period is 5 days.

MK-0941DRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 14 days after last dose of study drug

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 72 hours after study drug administration

Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941