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

Phase 1

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MK6349

• Registration Number: NCT00943371
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-09
• Study Completion: 2009-05
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

• Subject is on insulin or a PPAR agonist medication
• Subject has Type 1 diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MK6349	MK6349

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences	Through 30 days after the last dose of study drug
15-Hour weighted mean plasma glucose (WMG) concentration	15 hours postdose

Secondary Outcome Measures

Name	Time	Method
4-Hour weighted mean plasma glucose (WMG) concentration	4 hours postdose