Not Signed In -
Hemochromatosis, type 3 |
idiopathic hemochromatosis |
Clinical Trial: Study In People With Type 2 Diabetes
This study is not yet open for patient recruitment.
Verified by GlaxoSmithKline September 2005
|
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
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
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
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- Hemochromatosis, type 3 (Genetics Home Reference)
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