A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

NCT ID: NCT00067951

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-17

Study Completion Date

2004-11-30

Brief Summary

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The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rosiglitazone/metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Laboratory result for HbA1c \>11% or FPG \>270mg/dL
* Clinical diagnosis of Type II diabetes
* Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion Criteria

* Women who are pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Anniston, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Encinitas, California, United States

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Fullerton, California, United States

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Los Banos, California, United States

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Mission Viejo, California, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Saint Cloud, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Fayetteville, Georgia, United States

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Woodstock, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Newburgh, Indiana, United States

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Slidell, Louisiana, United States

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Jackson, Mississippi, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Kingston, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Mogadore, Ohio, United States

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Downingtown, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Johnson City, Tennessee, United States

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Arlington, Texas, United States

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Beaumont, Texas, United States

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Bryan, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Wenatchee, Washington, United States

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Camperdown, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Kippa-Ring, Queensland, Australia

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Woolloongabba, Queensland, Australia

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North Adelaide, South Australia, Australia

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Caulfield, Victoria, Australia

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Fremantle, Western Australia, Australia

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Perth, Western Australia, Australia

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Calgary, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Courtice, Ontario, Canada

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Kitchener, Ontario, Canada

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North Bay, Ontario, Canada

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Oshawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Peterborough, Ontario, Canada

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Renfrew, Ontario, Canada

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Stoney Creek, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Plessisville, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Saint Insidore de Dorchester, Quebec, Canada

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Saint-Marc-des-Carrieres, Quebec, Canada

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Sainte Jerome, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Auckland, , New Zealand

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Rotorua, , New Zealand

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Wellington, , New Zealand

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Pusan, , South Korea

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Seoul, , South Korea

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Uijeongbu-si, , South Korea

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Countries

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United States Australia Canada New Zealand South Korea

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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712753/004

Identifier Type: -

Identifier Source: org_study_id

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