NCT00543556

Brief Summary

This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
514

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2001

Typical duration for phase_2 type-2-diabetes-mellitus

Status
terminated

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

October 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

October 5, 2007

Last Update Submit

June 12, 2015

Conditions

Type 2 Diabetes Mellitus

Interventions

MK0767DRUG

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive
  • Patient is willing to discontinue current therapy for the duration of the study
  • Patient is not a heavy drinker

You may not qualify if:

  • Patient has a history of Type 1 diabetes and/or ketoacidosis
  • Patient has severe diabetic retinopathy, or nephropathy, or neuropath
  • Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1
  • Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0767

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 15, 2007

Study Start

October 1, 2001

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

June 15, 2015

Record last verified: 2015-06