Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
Pioglitazone Versus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
2 other identifiers
interventional
719
1 country
67
Brief Summary
Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with Type 2 Diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus
Started Sep 2000
Typical duration for phase_3 diabetes-mellitus
67 active sites
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
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 30, 2006
CompletedFirst Posted
Study publicly available on registry
May 31, 2006
CompletedFebruary 28, 2012
February 1, 2012
3.5 years
May 30, 2006
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in fasting triglyceride level
Final Visit
Secondary Outcomes (20)
Change in fasting low-density lipoprotein cholesterol.
Final Visit
Change in fasting high-density lipoprotein cholesterol.
Final Visit
Change in fasting total cholesterol.
Final Visit
Change in fasting free fatty acids.
Final Visit
Change in plasminogen activator inhibitor 1
Final Visit
- +15 more secondary outcomes
Study Arms (2)
Pioglitazone QD
EXPERIMENTALRosiglitazone QD
ACTIVE COMPARATORInterventions
Pioglitazone 30 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to pioglitazone 45 mg, capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks
Rosiglitazone 4 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to rosiglitazone 4 mg, capsules, orally, twice daily for up to 12 weeks
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus according to the World Health Organization criteria and have diabetes-associated dyslipidemia (fasting triglycerides level between greater than or equal to 150 mg per dL and less than or equal to 600 mg per dL, and a fasting direct low-density lipoprotein cholesterol less than or equal to 130 mg per dL).
- Fasting serum C-peptide greater than or equal to1 ng per
- Glycosylated hemoglobin greater than or equal to 7% and less than or equal to 11% if naive to oral antihyperglycemic medications, or greater than or equal to 9.5% if previously treated with oral antihyperglycemic monotherapy
You may not qualify if:
- Investigator site personnel and their immediate families. Immediate family defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Treatment with a drug within 30 days of Visit 1 that had not received regulatory approval.
- Treatment within 60 days of Visit 1 with any of the following:
- insulin
- systemic glucocorticoid therapy (excluding topical and inhaled preparations)
- combination glycemic therapy (two or more oral anti-diabetes medications)
- any lipid-lowering agent (including nicotinic acid, fibrates, bile acid resin binders, statins, d thyroxine or neomycin)
- any weight loss agent (prescription or over the counter)
- Pregnant, breast feeding, or intending to become pregnant during the study.
- Serum creatinine greater than or equal to 176.8 μmol per L or greater than or equal to 2 plus per dipstick.
- Proteinuria at Visit 1.
- Alanine transaminase or aspartate transaminase greater than or equal to 1.5 times the upper limit of normal at Visit 1 or had significant clinical signs or symptoms of liver disease.
- History of signs or symptoms of liver disease, such as jaundice or alanine transaminase greater than or equal to 1.5 times the upper limit of normal, while treated with any thiazolidinedione
- Hemoglobin less than 10.5 g per dL for females and less than11.5 g per dL for males at Visit 1.
- Clinically or biochemically based on thyroid stimulating hormone at Visit 1 hypothyroid or hyperthyroid.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Eli Lilly and Companycollaborator
Study Sites (67)
Unknown Facility
Anniston, Alabama, 36207, United States
Unknown Facility
Birmingham, Alabama, 35234, United States
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Tucson, Arizona, 85710, United States
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Concord, California, 94520, United States
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Fremont, California, 94538, United States
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Los Angeles, California, 90095, United States
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Palos Verdes Estates, California, 90274, United States
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San Diego, California, 92120, United States
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Santa Barbara, California, 93105, United States
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Santa Rosa, California, 95405, United States
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Aurora, Colorado, 80010, United States
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Englewood, Colorado, 80110, United States
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Avon, Connecticut, 06001, United States
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Hamden, Connecticut, 06518, United States
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Longwood, Florida, 32750, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33136, United States
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Atlanta, Georgia, 30342, United States
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Fayetteville, Georgia, 30214, United States
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Honolulu, Hawaii, 96814, United States
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Idaho Falls, Idaho, 83404, United States
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Chicago, Illinois, 60610, United States
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Indianapolis, Indiana, 46202, United States
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South Bend, Indiana, 46601, United States
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New Orleans, Louisiana, 70127, United States
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Baltimore, Maryland, 21204, United States
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Frederick, Maryland, 21702, United States
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Salisbury, Massachusetts, 01952, United States
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South Yarmouth, Massachusetts, 02664, United States
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Waltham, Massachusetts, 02453, United States
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Minneapolis, Minnesota, 55416, United States
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Chesterfield, Missouri, 63017, United States
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Omaha, Nebraska, United States
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East Setauket, New York, 11733, United States
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Endwell, New York, 13760, United States
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New York, New York, 10025, United States
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Rochester, New York, 14607, United States
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Staten Island, New York, 10305, United States
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Charlotte, North Carolina, 28211, United States
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Durham, North Carolina, 27713, United States
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Greenville, North Carolina, 27834, United States
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Morehead City, North Carolina, 28557, United States
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Wilmington, North Carolina, 28412, United States
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Columbus, Ohio, 43210, United States
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Franklin, Ohio, 45005, United States
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Tulsa, Oklahoma, 74136, United States
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Portland, Oregon, 97201, United States
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Salem, Oregon, 97302, United States
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Philadelphia, Pennsylvania, 19124, United States
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Pottstown, Pennsylvania, 19464, United States
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Providence, Rhode Island, 02908, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Knoxville, Tennessee, 37909, United States
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Memphis, Tennessee, 38119, United States
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Beaumont, Texas, 77701, United States
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Conroe, Texas, 77384, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77024, United States
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Lake Jackson, Texas, 77566, United States
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San Antonio, Texas, 78229, United States
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Ogden, Utah, 84403, United States
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Mechanicsville, Virginia, 23111, United States
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Newport News, Virginia, 23606, United States
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Virginia Beach, Virginia, 23455, United States
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Federal Way, Washington, 98003, United States
Unknown Facility
Wenatchee, Washington, 98801, United States
Unknown Facility
Milwaukee, Wisconsin, 53209, United States
Related Publications (3)
Goldberg RB, Kendall DM, Deeg MA, Buse JB, Zagar AJ, Pinaire JA, Tan MH, Khan MA, Perez AT, Jacober SJ; GLAI Study Investigators. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2005 Jul;28(7):1547-54. doi: 10.2337/diacare.28.7.1547.
PMID: 15983299RESULTTilden DP, Mariz S, O'Bryan-Tear G, Bottomley J, Diamantopoulos A. A lifetime modelled economic evaluation comparing pioglitazone and rosiglitazone for the treatment of type 2 diabetes mellitus in the UK. Pharmacoeconomics. 2007;25(1):39-54. doi: 10.2165/00019053-200725010-00005.
PMID: 17192117RESULTDeeg MA, Buse JB, Goldberg RB, Kendall DM, Zagar AJ, Jacober SJ, Khan MA, Perez AT, Tan MH; GLAI Study Investigators. Pioglitazone and rosiglitazone have different effects on serum lipoprotein particle concentrations and sizes in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2007 Oct;30(10):2458-64. doi: 10.2337/dc06-1903. Epub 2007 Jun 26.
PMID: 17595355RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alfonso Perez, MD
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2006
First Posted
May 31, 2006
Study Start
September 1, 2000
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
February 28, 2012
Record last verified: 2012-02