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

March 19, 2018 updated by: GlaxoSmithKline

An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • GSK Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • GSK Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • GSK Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • GSK Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • GSK Investigational Site
    • Victoria
      • Caulfield, Victoria, Australia, 3162
        • GSK Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6959
        • GSK Investigational Site
      • Perth, Western Australia, Australia, 6000
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0C5
        • GSK Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • GSK Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • GSK Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3T1
        • GSK Investigational Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • GSK Investigational Site
      • Courtice, Ontario, Canada, L1E 3C3
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2C 2N9
        • GSK Investigational Site
      • North Bay, Ontario, Canada, P1B 2H3
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1H 1C2
        • GSK Investigational Site
      • Peterborough, Ontario, Canada, K9J 7B3
        • GSK Investigational Site
      • Peterborough, Ontario, Canada, K9H 5G1
        • GSK Investigational Site
      • Renfrew, Ontario, Canada, K7V 1P6
        • GSK Investigational Site
      • Stoney Creek, Ontario, Canada, L8G 2V6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • GSK Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3S 2W1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H4N 2W2
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1V 1X4
        • GSK Investigational Site
      • Plessisville, Quebec, Canada, G6L 3J1
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Saint Insidore De Dorchester, Quebec, Canada, G0S 2S0
        • GSK Investigational Site
      • Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
        • GSK Investigational Site
      • Sainte Jerome, Quebec, Canada, J7Z 5T3
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 3X1
        • GSK Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 0M5
        • GSK Investigational Site
  • Korea, Republic of
      • Pusan, Korea, Republic of, 602-739
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 139-872
        • GSK Investigational Site
      • Uijeongbu,, Korea, Republic of, 480-821
        • GSK Investigational Site
  • New Zealand
      • Auckland, New Zealand, 1701
        • GSK Investigational Site
      • Auckland, New Zealand, 1311
        • GSK Investigational Site
      • Christchurch, New Zealand, 8001
        • GSK Investigational Site
      • Rotorua, New Zealand, 3201
        • GSK Investigational Site
      • Wellington, New Zealand, 6035
        • GSK Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • GSK Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85014
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85745
        • GSK Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • GSK Investigational Site
      • Fullerton, California, United States, 92835
        • GSK Investigational Site
      • Los Banos, California, United States, 93635
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32204
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Fayetteville, Georgia, United States, 30214
        • GSK Investigational Site
      • Woodstock, Georgia, United States, 30189
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • GSK Investigational Site
      • Newburgh, Indiana, United States, 47630
        • GSK Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64111
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63376
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • GSK Investigational Site
    • New York
      • Kingston, New York, United States, 12401
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10024
        • GSK Investigational Site
      • New York, New York, United States, 10029
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • GSK Investigational Site
    • Ohio
      • Mogadore, Ohio, United States, 44260
        • GSK Investigational Site
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • GSK Investigational Site
      • Warminster, Pennsylvania, United States, 18974
        • GSK Investigational Site
      • West Chester, Pennsylvania, United States, 19382
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76017
        • GSK Investigational Site
      • Beaumont, Texas, United States, 77701
        • GSK Investigational Site
      • Bryan, Texas, United States, 77802
        • GSK Investigational Site
      • Corpus Christi, Texas, United States, 78411
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Midland, Texas, United States, 79705
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78221
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78237
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • GSK Investigational Site
      • Spokane, Washington, United States, 99207
        • GSK Investigational Site
      • Wenatchee, Washington, United States, 98801
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2003

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 712753/004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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