Efficacy and Safety Study of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes.

Condition(s) targeted: Diabetes Mellitus

Intervention: Pioglitazone HCL+ Metformin HCL (Drug); Pioglitazone HCL (Drug); Metformin HCL (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Alfonso Perez, MD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.

Overall contact:
Brigit Isaacson, Phone: 877-872-3700, Ext: 5394, Email: bisaacson@tgrd.com

This is a safety and efficacy study of pioglitazone 15 mg and metformin 850 mg combination therapy compared to pioglitazone 15 mg by itself and metformin 850 mg by itself in treating subjects with type 2 diabetes.

Official title: A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The change from baseline in hemoglobin Alc.

Secondary outcome:

The change from Baseline in fasting plasma glucose, fasting insulin, Homeostasis Model Assessment, high sensitivity C-reactive protein, adiponectin and lipid fractionation.

The change from Baseline in lipid parameters (total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides).

Detailed description: Subjects participating in this study will be randomized to receive either 15 mg of pioglitazone HCL, 850 mg of metformin HCL or a combination of 15 mg pioglitazone HCL and 850 mg metformin HCL taken twice daily for 24 weeks. On study visits days, subjects will be required to fast for a minimum of 8 hours prior to laboratory tests.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject has type 2 diabetes.

- The subject has received no treatment with antidiabetic medication in the 12 weeks

prior to Screening, other than short-term use defined as ≤15 days.

- The subject has a hemoglobin Alc ≥7. 5% and ≤10. 0% at Screening. NOTE: if the subject

does not qualify based on this criterion alone, the hemoglobin Alc may be repeated in one week.

- The subject is stable as determined by a physician (ie, via medical history and

physical examination).

- The subject has a body mass index ≤45 kg/m2.

- The subject has received counseling on lifestyle modification for type 2 diabetes,

including diet and exercise.

Exclusion Criteria:

- The subject has type 1 diabetes.

- The subject has unstable angina or heart failure of any etiology with New York Heart

Association functional class III or IV.

- The subject has a 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 subject has a serum creatinine level ≥1. 5 mg/dL (≥133 μmol/L) or female subject

has a serum creatinine level ≥1. 4 mg/dL (≥124 μmol/L).

- The subject has a triglyceride level >500 mg/dL (>5. 65 mmol/L).

- Male subject has a hemoglobin level <10. 5 g/dL (<105 g/L) or female subject has a

hemoglobin level <10. 0 g/dL (<100 g/L).

- The subject has an alanine aminotransferase level of greater than 2. 5 times the upper

limit of normal, active liver disease, or jaundice.

- The subject has a 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.

- The subject has been discontinued from a thiazolidinedione or metformin therapy due to

lack of efficacy or clinical or laboratory signs of intolerance.

- The subject is currently participating in another investigational study or has

participated in an investigational study within 30 days prior to randomization

- The subject has a 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.

- The subject has a history of acute or chronic metabolic acidosis, including diabetic

ketoacidosis with or without coma.

- The subject has any disease or condition at Screening or Randomization that would

compromise subject safety, might affect life expectancy, or would make it difficult to successfully manage and follow the subject according to the protocol.

Brigit Isaacson, Phone: 877-872-3700, Ext: 5394, Email: bisaacson@tgrd.com

Providencia-Santiago, Chile; Recruiting

Temuco, Chile; Recruiting

Guayma, Puerto Rico; Recruiting

Ciales, Puerto Rico; Recruiting

Coto Laurel, Puerto Rico; Recruiting

Caguas, Puerto Rico; Recruiting

Guaynabo, Puerto Rico; Recruiting

Rio Piedras, Puerto Rico; Recruiting

Aibonito, Puerto Rico; Recruiting

Pell City, Alabama, United States; Recruiting

Montgomery, Alabama, United States; Recruiting

Haleyville, Alabama, United States; Recruiting

Birmingham, Alabama, United States; Recruiting

Phoenix, Arizona, United States; Recruiting

Tucson, Arizona, United States; Recruiting

Santa Ana, California, United States; Recruiting

Norwalk, California, United States; Recruiting

Los Angeles,, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Artesia, California, United States; Recruiting

Anaheim, California, United States; Recruiting

Orange, California, United States; Recruiting

Dinuba, California, United States; Recruiting

Pueblo, Colorado, United States; Recruiting

St Petersburg, Florida, United States; Recruiting

Miami,, Florida, United States; Recruiting

Altamonte Springs, Florida, United States; Recruiting

Panama City, Florida, United States; Recruiting

Hialeah, Florida, United States; Recruiting

Plantation, Florida, United States; Recruiting

Coral Gables, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

St. Cloud, Florida, United States; Recruiting

Columbus, Georgia, United States; Recruiting

Boise, Idaho, United States; Recruiting

Coeur d' Alene,, Idaho, United States; Recruiting

Peoria, Illinois, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Flossmoor, Illinois, United States; Recruiting

Elkhart, Indiana, United States; Recruiting

Zapopan, Jalisco, Mexico; Recruiting

Shawnee,, Kansas, United States; Recruiting

Southfield, Michigan, United States; Recruiting

Chesterfield, Missouri, United States; Recruiting

Billings, Montana, United States; Recruiting

Elizabeth, New Jersey, United States; Recruiting

Fayetteville, New York, United States; Recruiting

New York, New York, United States; Recruiting

Pinehurst, North Carolina, United States; Recruiting

Durham, North Carolina, United States; Recruiting

Monterrey, Nuevo Leon, Mexico; Recruiting

Zanesville, Ohio, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Perrysburg, Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Eugene, Oregon, United States; Recruiting

Fleetwood, Pennsylvania, United States; Recruiting

Norristown, Pennsylvania, United States; Recruiting

Cranston, Rhode Island, United States; Recruiting

Simpsonville,, South Carolina, United States; Recruiting

Varnville, South Carolina, United States; Recruiting

Fayetteville, Tennessee, United States; Recruiting

San Antonio,, Texas, United States; Recruiting

Corpus Christi, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

North Richland Hills, Texas, United States; Recruiting

McAllen, Texas, United States; Recruiting

New Braunfels, Texas, United States; Recruiting

El Paso, Texas, United States; Recruiting

Mission, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Bountiful, Utah, United States; Recruiting

Petersburg, Virginia, United States; Recruiting

Port Orchard, Washington, United States; Recruiting

Spokane, Washington, United States; Recruiting

Starting date: June 2007
Ending date: August 2008
Last updated: July 30, 2008