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

Phase 1TerminatedNCT00943371

Merck Sharp & Dohme LLC28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

MK6349DRUG

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

Comparator: Placebo to MK6349DRUG

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

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

15-Hour weighted mean plasma glucose (WMG) concentration

Time frame: 15 hours postdose

Secondary Outcomes

4-Hour weighted mean plasma glucose (WMG) concentration

Time frame: 4 hours postdose

Data from ClinicalTrials.gov

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