NCT00282945

Brief Summary

The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

2 active sites

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, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

First QC Date

January 25, 2006

Last Update Submit

October 9, 2008

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • This study will examine whether biomarkers of B-cell function measured early in the study (1, 3, and/or 6 months) will predict long-term changes in B-cell function (as represented by HOMA-B).

Interventions

RosiglitazoneDRUG
MetforminDRUG

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%.
  • years of age.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Holon, 58100, Israel

Location

Pfizer Investigational Site

Jerusalem, 91120, Israel

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

RosiglitazoneMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

January 1, 2006

Study Completion

October 1, 2007

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations

IL(2)