NCT00547274

Brief Summary

The purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment. 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
111

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_3

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

July 1, 2003

Completed
4 months 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
4 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

October 19, 2007

Last Update Submit

June 11, 2015

Conditions

Diabetes Mellitus, Type IIDyslipidemia

Interventions

MK0767DRUG

Eligibility Criteria

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

You may qualify if:

  • Men and non-pregnant females
  • Age greater than or equal to 21 years
  • Stop current diabetes therapy (if applicable)
  • Stop current statin therapy (if applicable)

You may not qualify if:

  • History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin
  • Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks
  • Patients requiring treatment with corticosteroids for more than 14 consecutive days
  • Patients taking warfarin or warfarin-like anti-coagulants
  • Patients undergoing surgery within 30 days of Visit 1
  • Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease
  • Patients with history of pancreatitis or uncontrolled high blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dyslipidemias

Interventions

MK0767

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

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 19, 2007

First Posted

October 22, 2007

Study Start

July 1, 2003

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

June 12, 2015

Record last verified: 2015-06