Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
NCT ID: NCT00727857
Last Updated: 2011-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2007-06-30
2008-08-31
Brief Summary
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Detailed Description
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Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents.
This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.
Study participation is anticipated to be approximately 6.5 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pioglitazone 15 mg /Metformin 850 mg BID
Pioglitazone and metformin
Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.
Pioglitazone 15 mg BID
Pioglitazone
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.
Metformin 850 mg BID
Metformin
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Interventions
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Pioglitazone and metformin
Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.
Pioglitazone
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.
Metformin
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.
* A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.
* Body mass index less than or equal to 45 kg/m2.
* Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Stable condition as determined by a physician.
Exclusion Criteria
* Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
* History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.
* Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.
* Has a triglyceride level greater than 500 mg per dL.
* Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL.
* Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
* History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening.
* Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
* Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
* History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
* Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
* Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
* Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
* Antidiabetic medications other than study medication
* Chronically used oral or parenteral glucocorticoids
* Niacin greater than 200 mg per day, including niacin-containing products such as Advicor
* Chronically used steroid-joint injections
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Takeda Global Research & Development Center, Inc.
Principal Investigators
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VP Clinical Science Strategy
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Haleyville, Alabama, United States
Montgomery, Alabama, United States
Pell City, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Artesia, California, United States
Dinuba, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Norwalk, California, United States
Orange, California, United States
Santa Ana, California, United States
Santa Monica, California, United States
Pueblo, Colorado, United States
Altamonte Springs, Florida, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Panama City, Florida, United States
Plantation, Florida, United States
Saint Cloud, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Boise, Idaho, United States
Coeur d'Alene, Idaho, United States
Chicago, Illinois, United States
Flossmoor, Illinois, United States
Peoria, Illinois, United States
Elkhart, Indiana, United States
Shawnee, Kansas, United States
Southfield, Michigan, United States
Chesterfield, Missouri, United States
Billings, Montana, United States
Elizabeth, New Jersey, United States
Fayetteville, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Pinehurst, North Carolina, United States
Cincinnati, Ohio, United States
Perrysburg, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Fleetwood, Pennsylvania, United States
Norristown, Pennsylvania, United States
Cranston, Rhode Island, United States
Simpsonville, South Carolina, United States
Varnville, South Carolina, United States
Fayetteville, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Mission, Texas, United States
New Braunfels, Texas, United States
North Richland Hills, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
Petersburg, Virginia, United States
Port Orchard, Washington, United States
Spokane, Washington, United States
Providencia-Santiago, , Chile
Temuco, , Chile
Zapopan, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Aibonito, , Puerto Rico
Caguas, , Puerto Rico
Ciales, , Puerto Rico
Coto Laurel, , Puerto Rico
Guayma, , Puerto Rico
Guaynabo, , Puerto Rico
Rio Piedras, , Puerto Rico
Countries
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References
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Perez A, Zhao Z, Jacks R, Spanheimer R. Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. Curr Med Res Opin. 2009 Dec;25(12):2915-23. doi: 10.1185/03007990903350011.
Perez A, Jacks R, Arora V, Spanheimer R. Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. J Clin Hypertens (Greenwich). 2010 Dec;12(12):973-82. doi: 10.1111/j.1751-7176.2010.00389.x. Epub 2010 Nov 8.
Related Links
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Other Identifiers
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U1111-1114-0371
Identifier Type: REGISTRY
Identifier Source: secondary_id
01-06-TL-OPIMET-008
Identifier Type: -
Identifier Source: org_study_id