MK1006 Single Dose Study in Japanese Type 2 Diabetes Patients

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00791661

First received: November 10, 2008

Last updated: November 30, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2008

Last Updated Date

November 30, 2009

Start Date ^ICMJE

November 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00791661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

MK1006 Single Dose Study in Japanese Type 2 Diabetes Patients

Official Title ^ICMJE

A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006 in Japanese Subjects With Type 2 Diabetes

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus, Non-Insulin-Dependent

Intervention ^ICMJE

Drug: MK1006
MK1006 capsules in single dose beginning at 15 mg and rising to 170 mg
Drug: Comparator: placebo
Placebo capsules in single dose

Study Arm (s)

Experimental: 1
MK1006

Intervention: Drug: MK1006
Placebo Comparator: 2
placebo

Intervention: Drug: Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00791661

Other Study ID Numbers ^ICMJE

2008_584, MK1006-005

Has Data Monitoring Committee

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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