NCT00511667

Brief Summary

A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started May 2007

Typical duration for phase_1 type-2-diabetes-mellitus

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 26, 2012

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 2, 2007

Results QC Date

April 4, 2012

Last Update Submit

August 23, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Participants With Any Clinical Adverse Experience

    Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

  • Participants Discontinued Because of Any Clinical Adverse Experience

    Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Secondary Outcomes (5)

  • Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941

    Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  • Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941

    Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  • Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941

    Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  • Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941

    Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  • Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941

    Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

Study Arms (2)

MK0941

EXPERIMENTAL
Drug: MK0941

Placebo

PLACEBO COMPARATOR
Drug: Comparator: Placebo

Interventions

MK0941DRUG

MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

MK0941
Comparator: PlaceboDRUG

Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nonsmoking Male or Female (of non-child bearing potential)
  • Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
  • Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

You may not qualify if:

  • Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
  • Subject is on 3 or more oral anti-diabetes medications
  • Subject has a history of type 1 diabetes
  • Subject has a diagnosis of glaucoma or is blind
  • Subject has had trauma to one or both eyes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

August 2, 2007

First Posted

August 6, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 24, 2016

Results First Posted

June 26, 2012

Record last verified: 2016-08