MK1006 Single Dose Study in Japanese Type 2 Diabetes Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00791661

Purpose

A single rising dose study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of MK1006 in Japanese patients with Type 2 Diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: MK1006 Drug: Comparator: placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006 in Japanese Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Any clinical or laboratory experiences [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma pharmacokinetics of MK1006 and reduction in plasma glucose concentrations [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2011
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK1006	Drug: MK1006 MK1006 capsules in single dose beginning at 15 mg and rising to 170 mg
2: Placebo Comparator placebo	Drug: Comparator: placebo Placebo capsules in single 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 Diet And Exercise Alone Or Single Oral Anti-Hyperglycemic Agent

Exclusion Criteria:

Subject Has A History Of Type 1 Diabetes
Subject Is Being Treated With Glaucoma Medications
Subject Has Had 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 & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_584, MK1006-005
Study First Received:	November 10, 2008
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00791661 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 10, 2009