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

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

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

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: MK6349; Drug: Comparator: Placebo to MK6349

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
4-Hour weighted mean plasma glucose (WMG) concentration	4 hours postdose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 6349-002; MK6349-002; 2007_597

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No