NCT00130806

Brief Summary

This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

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

Timeline
Completed

Started Sep 2005

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

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2005

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

August 12, 2005

Last Update Submit

September 6, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • The difference in daily dose requirements of insulin after 24 weeks

Secondary Outcomes (1)

  • (a) HbA1C; (b) FPG; (c) Percent of patients with HbA1C <7.0%; (d) TG, HDL-C, non-HDL-C and apolipoprotein B; (e) Free Fatty Acids (FFA); (f) the incidence of hypoglycemic events at 24 weeks

Interventions

MK0478 (muraglitazar)DRUG
Comparator: placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.)

You may not qualify if:

  • People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

muraglitazar

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

August 12, 2005

First Posted

August 16, 2005

Study Start

September 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

September 7, 2016

Record last verified: 2016-09