MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005 AM1)(COMPLETED) - Full Text View

Purpose

A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: MK-1006 Drug: Placebo	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 Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-1006 in Japanese Subject 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 [ Time Frame: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days) ] [ Designated as safety issue: Yes ]
An adverse event 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.
Number of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: up to approximately 17 days ] [ Designated as safety issue: Yes ]
An adverse event 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.

Secondary Outcome Measures:

Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 [ Time Frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) ] [ Designated as safety issue: No ]
AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.
Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 [ Time Frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) ] [ Designated as safety issue: No ]
AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.
Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 [ Time Frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) ] [ Designated as safety issue: No ]
The placebo group was not evaluated for this outcome measure.
Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 [ Time Frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) ] [ Designated as safety issue: No ]
The placebo group was not evaluated for this outcome measure.
Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 [ Time Frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) ] [ Designated as safety issue: No ]
The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.
24-hour Weighted Mean Glucose (WMG) Concentration [ Time Frame: Up to 36 hours ] [ Designated as safety issue: No ]
Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.

Enrollment:	24
Study Start Date:	November 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Panel A: MK-1006 15/30/45 Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.	Drug: MK-1006 MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C. Drug: Placebo Matching placebo to MK-1006 in a single oral dose
Experimental: Panel B: MK-1006 60/80/60 fed Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.	Drug: MK-1006 MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C. Drug: Placebo Matching placebo to MK-1006 in a single oral dose
Experimental: Panel C: MK-1006 100/140/170 Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.	Drug: MK-1006 MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C. Drug: Placebo Matching placebo to MK-1006 in a single oral dose

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese male or female between 20 to 64 years of age
Diagnosis of type 2 diabetes
Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

Exclusion Criteria:

Subject has a history of type 1 diabetes mellitus
Subject has a clinical diagnosis of glaucoma
Subject has donated blood or participated in another clinical study in the past 12 weeks
Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791661

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00791661 History of Changes
Other Study ID Numbers:	MK-1006-005, 2008_584
Study First Received:	November 10, 2008
Results First Received:	September 7, 2012
Last Updated:	November 27, 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 23, 2013