A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943371
First received: July 21, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK6349
Drug: Comparator: Placebo to MK6349
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 Double-Blind, Randomized, Placebo-Controlled, Single and Divided Rising-Dose, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6349 in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences [ Time Frame: Through 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
  • 15-Hour weighted mean plasma glucose (WMG) concentration [ Time Frame: 15 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 4-Hour weighted mean plasma glucose (WMG) concentration [ Time Frame: 4 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK6349
Drug: MK6349
Panel A: MK6349 in single doses beginning at 16 mg and rising to 90 mg in up to four treatment periods Panel B: MK6349 in single doses beginning at 90 mg and rising to 160 mg in up to four treatment periods Panel C: MK6349 in divided doses beginning at 20 mg q.a.c. (before each meal) and rising to 50 mg q.a.c. in up to four treatment periods
Placebo Comparator: 2
Placebo to MK6349
Drug: Comparator: Placebo to MK6349
Panel A: Placebo to MK6349 in single doses in up to four treatment periods Panel B: Placebo to MK6349 in single doses in up to four treatment periods Panel C: MK6349 in divided doses q.a.c. (before each meal) in up to four treatment periods

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age
  • Subject has Type 2 Diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs

Exclusion Criteria:

  • Subject is on insulin or a PPAR agonist medication
  • Subject has Type 1 diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943371

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00943371     History of Changes
Other Study ID Numbers: 2007_597, MK6349-002
Study First Received: July 21, 2009
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014