NCT00543751

Brief Summary

The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control 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
610

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3 diabetes-mellitus-type-2

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

January 1, 2003

Completed
10 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
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 17, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

October 5, 2007

Last Update Submit

June 16, 2015

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0767DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy
  • Non-pregnant females

You may not qualify if:

  • Patients with Type 1 Diabetes or history of ketoacidosis
  • Patients who have been treated with insulin or other antihyperglycemic agents
  • Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease

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 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

January 1, 2003

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

June 17, 2015

Record last verified: 2015-06