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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754130
• Other study ID #: 0941-011
• Secondary ID: 2008_023MK-0941-
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2008
• Last updated: February 23, 2015
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No