NCT00943371

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1 type-2-diabetes-mellitus

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

July 21, 2009

Last Update Submit

August 26, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 4-Hour weighted mean plasma glucose (WMG) concentration

    4 hours postdose

Study Arms (2)

1

EXPERIMENTAL

MK6349

Drug: MK6349

2

PLACEBO COMPARATOR

Placebo to MK6349

Drug: Comparator: Placebo to MK6349

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

1
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

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 22, 2009

Study Start

August 1, 2007

Primary Completion

September 1, 2007

Study Completion

May 1, 2009

Last Updated

August 27, 2015

Record last verified: 2015-08