A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)

NCT ID: NCT00943371

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-05-31

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

MK6349

Group Type: EXPERIMENTAL

MK6349

Intervention Type: DRUG

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

2

Placebo to MK6349

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo to MK6349

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK6349-002

Identifier Type: -

Identifier Source: secondary_id

2007_597

Identifier Type: -

Identifier Source: secondary_id

6349-002

Identifier Type: -

Identifier Source: org_study_id