NCT00543738

Brief Summary

A study to test the effects of MK0767 when added to Metformin in patients with inadequately controlled Type 2 Diabetes Mellitus. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
114

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_3 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

June 1, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
3.8 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 17, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

October 5, 2007

Last Update Submit

June 16, 2015

Conditions

Diabetes Mellitus

Interventions

MK0767DRUG

Eligibility Criteria

Age21 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All women of childbearing potential must have a negative urine pregnancy test prior to starting the study
  • Patients must be on a stable dose of metformin for at least 2 weeks prior to visit 2

You may not qualify if:

  • Patients with a history of type 1 diabetes mellitus and/or history of ketoacidosis
  • Patients on estrogen replacement therapy regimen or SERM
  • Patients with history of, allergy to, intolerance or hypersensitivity to statins or fibric acid derivatives, including history of elevated muscle and liver function tests, jaundice, hepatoxicity, or myopathy associated with these treatments
  • Patient is on a weight loss program with ongoing weight loss or starting an intensive exercise program within 4 weeks from starting the study
  • Have active liver or gall bladder disease
  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

MK0767

Condition Hierarchy (Ancestors)

Glucose 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 3
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

June 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

June 17, 2015

Record last verified: 2015-06