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

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: Placebo Drug: MK-0941	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]
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:

Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
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: Time to Reach Cmax (Tmax) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
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) [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 5 and Day 1 ] [ Designated as safety issue: No ]
Geometric Mean of the Day 5 to Day 1 Accumulation Ratio

Enrollment:	16
Study Start Date:	September 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754130

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00754130 History of Changes
Other Study ID Numbers:	0941-011, 2008_023, MK-0941-011
Study First Received:	September 16, 2008
Results First Received:	August 31, 2012
Last Updated:	August 31, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013