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Study In People With Type 2 Diabetes - Article


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Gaucher disease, type 3

Norrbottnian Gaucher disease; Subacute Neuronopathic Gaucher Disease; Type 3 Gaucher Disease 



Clinical Trial: Study In People With Type 2 Diabetes

This study is not yet open for patient recruitment.
Verified by GlaxoSmithKline September 2005

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00196989

Purpose

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM.
Condition Intervention Phase
Type 2 Diabetes Mellitus
  Drug: Pioglitazone
 Drug: GW677954
 Phase II

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or Exercise Treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus

Further Study Details: 
Primary Outcomes: Improvement in glucose control over a 16 week period.
Secondary Outcomes: Cholesterol, additional glycemic endpoints, safety endpoints
Expected Total Enrollment:  448

Study start: September 2005

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion criteria:

  • Type 2 diabetes.
  • Diet and/or exercise treated or receiving stable metformin monotherapy.
  • Must have an HbA1c level between 8.0% and 10.0%, with FPG < 270 mg/dL (15.0 mmol/L) at screening.
  • Generally in good health.

Exclusion criteria:

  • Use of lipid lowering agents (including statins, fibrates and ezetimibe), niacin, fat absorption blocking agents, and bile acid sequestrants.
  • Familial hypercholesterolemia, a history of triglycerides (TGs) in excess of 800 mg/dL (8.96 mmol/L), a history of pancreatitis or a documented recent history of clinically significant cardiovascular disease.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00196989


Alabama
      GSK Clinical Trials Call Center, Northport,  Alabama,  35476,  United States
Craig Buettney  877-379-3718 

      GSK Clinical Trials Call Center, Birmingham,  Alabama,  35205,  United States
Scott Touger  877-379-3718 

Arizona
      GSK Clinical Trials Call Center, Phoenix,  Arizona,  85006,  United States
Frank Agnone  877-379-3718 

      GSK Clinical Trials Call Center, Phoenix,  Arizona,  85006,  United States
Frank Agnone  877-379-3718 

      GSK Clinical Trials Call Center, Chandler,  Arizona,  85224,  United States
Donna DeSantis  877-379-3718 

      GSK Clinical Trials Call Center, Phoenix,  Arizona,  85032,  United States
Lawrence Gassner  877-379-3718 

California
      GSK Clinical Trials Call Center, Los Angeles,  California,  90057,  United States
Andrew Lewin  877-379-3718 

      GSK Clinical Trials Call Center, Los Angeles,  California,  90033,  United States
Manuel Quinones  877-379-3718 

      GSK Clinical Trials Call Center, Long Beach,  California,  90806,  United States
Deanna Cheung  877-379-3718 

      GSK Clinical Trials Call Center, San Diego,  California,  92128,  United States
Belinda Dure-Smith  877-379-3718 

      GSK Clinical Trials Call Center, Pasadena,  California,  91105,  United States
Michael Lin  877-379-3718 

      GSK Clinical Trials Call Center, Inglewood,  California,  90301,  United States
Crandford Scott  877-379-3718 

Colorado
      GSK Clinical Trials Call Center, Denver,  Colorado,  80220,  United States
Jane Reusch  877-379-3718 

Connecticut
      GSK Clinical Trials Call Center, Norwich,  Connecticut,  06360,  United States
Christopher Sorli  877-379-3718 

Florida
      GSK Clinical Trials Call Center, Miami,  Florida,  33176,  United States
Peter Weissman  877-379-3718 

      GSK Clinical Trials Call Center, Hollywood,  Florida,  33023,  United States
Gregory Serfer  877-379-3718 

      GSK Clinical Trials Call Center, St. Cloud,  Florida,  34769,  United States
John Wilker  877-379-3718 

      GSK Clinical Trials Call Center, Largo,  Florida,  33773,  United States
C. David Wingfield  877-379-3718 

      GSK Clinical Trials Call Center, Sarasota,  Florida,  34232,  United States
Joseph Millin  877-379-3718 

Georgia
      GSK Clinical Trials Call Center, Atlanta,  Georgia,  30342,  United States
James Capo  877-379-3718 

      GSK Clinical Trials Call Center, Duluth,  Georgia,  30097,  United States
Lee Herman  877-379-3718 

Hawaii
      GSK Clinical Trials Call Center, Honolulu,  Hawaii,  96813,  United States
Richard Arakaki  877-379-3718 

Massachusetts
      GSK Clinical Trials Call Center, West Yarmouth,  Massachusetts,  02673,  United States
Phyllis Troia  877-379-3718 

Montana
      GSK Clinical Trials Call Center, St. Louis,  Montana,  63141,  United States
Andrea Baxter  877-379-3718 

      GSK Clinical Trials Call Center, St. Louis,  Montana,  63110,  United States
Janet McGill  877-379-3718 

Nevada
      GSK Clinical Trials Call Center, Las Vegas,  Nevada,  89128,  United States
Timothy Ladner  877-379-3718 

      GSK Clinical Trials Call Center, Henderson,  Nevada,  89015,  United States
Mostafa Sheta  877-379-3718 

      GSK Clinical Trials Call Center, Pahrump,  Nevada,  89048,  United States
Georges Tannoury  877-379-3718 

      GSK Clinical Trials Call Center, Las Vegas,  Nevada,  89119,  United States
V. Jerome Mirkil  877-379-3718 

      GSK Clinical Trials Call Center, Henderson,  Nevada,  89015,  United States
Peter Philander  877-379-3718 

New Mexico
      GSK Clinical Trials Call Center, Albuquerque,  New Mexico,  87102,  United States
Ellen Kim  877-379-3718 

      GSK Clinical Trials Call Center, Santa Fe,  New Mexico,  87505,  United States
Joshua Brown  877-379-3718 

New York
      GSK Clinical Trials Call Center, New York,  New York,  10032,  United States
Daniel Donovan  877-379-3718 

North Carolina
      GSK Clinical Trials Call Center, Greensboro,  North Carolina,  27401,  United States
Alexander Murray  877-379-3718 

Ohio
      GSK Clinical Trials Call Center, Cleveland,  Ohio,  44195,  United States
Byron Hoogwerf  877-379-3718 

Pennsylvania
      GSK Clinical Trials Call Center, Philadelphia,  Pennsylvania,  19107,  United States
Serge Jabbour  877-379-3718 

Rhode Island
      GSK Clinical Trials Call Center, East Providence,  Rhode Island,  02914,  United States
Mitchell Pressman  877-379-3718 

South Carolina
      GSK Clinical Trials Call Center, Simpsonville,  South Carolina,  29681,  United States
Robert Broker  877-379-3718 

      GSK Clinical Trials Call Center, Greer,  South Carolina,  29651,  United States
Phillip Snell  877-379-3718 

Tennessee
      GSK Clinical Trials Call Center, Kingsport,  Tennessee,  37660,  United States
Emily Morawski  877-379-3718 

Texas
      GSK Clinical Trials Call Center, Tyler,  Texas,  75708,  United States
David Shafer  877-379-3718 

      GSK Clinical Trials Call Center, Dallas,  Texas,  75246,  United States
Priscilla Hollander  877-379-3718 

      GSK Clinical Trials Call Center, San Antonio,  Texas,  78229,  United States
Sherwyn Schwartz  877-379-3718 

Utah
      GSK Clinical Trials Call Center, West Jordan,  Utah,  84084,  United States
Randall Watson  877-379-3718 

      GSK Clinical Trials Call Center, Salt Lake City,  Utah,  84109,  United States
Dan Henry  877-379-3718 

Virginia
      GSK Clinical Trials Call Center, Virginia Beach,  Virginia,  23445,  United States
Stephen Kayota  877-379-3718 

Washington
      GSK Clinical Trials Call Center, Edmonds,  Washington,  98026,  United States
Robert Bettis  877-379-3718 

Wisconsin
      GSK Clinical Trials Call Center, Wauwatos,  Wisconsin,  53226,  United States
Samuel Idarraga  877-379-3718 

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  ADG20001
Last Updated:  September 19, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00196989
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20


Source: ClinicalTrials.gov
Cache Date: September 21, 2005

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Page Updated: September 6, 2005
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