A Study to Evaluate SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone, or Pioglitazone HCl Alone for the Treatment of Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: SYR-322, pioglitazone HCl (Drug)

Phase: Phase 3

Status: Active, not recruiting

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

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SYR-322 plus pioglitazone HCl, SYR-322 alone, or pioglitazone alone in subjects with type 2 diabetes.

Official title: A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone, or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HbA1c at end of study.

Detailed description: The purpose of the study is to evaluate the efficacy of the combination of SYR-322 with pioglitazone HCl in subjects with type 2 diabetes mellitus who are inadequately controlled on diet and exercise alone. Subjects will undergo necessary evaluations to determine eligibility for the study during a Screening period, and eligible subjects will participate in a Run-In/Stabilization period. Randomized subjects will receive treatment with SYR-322 plus pioglitazone HCl, SYR-322 alone, or pioglitazone alone, followed by a Follow-Up period. Subjects who complete the study will be eligible for continuing treatment in an open-label extension study.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject is male or female, 18 to 80 years of age, with type 2 diabetes mellitus,

experiencing inadequate glycemic control with diet and exercise alone.

- The subject has received less than 7 days of any antidiabetic agents within the 3

months prior to Screening.

- The subject has a HbA1c concentration between 7. 5 percent and 11 percent, inclusive

- Female subjects of childbearing potential (ie, not surgically sterile and/or not

postmenopausal) must be practicing adequate contraception.

Exclusion Criteria:

- The subject has a systolic blood pressure greater than or equal to 160 mm Hg and a

diastolic pressure greater than or equal to 100 mm Hg.

- The subject has a history of laser treatment for proliferative diabetic retinopathy

within the 6 months prior to Screening.

- The subject has a history of treated diabetic gastric paresis.

- The subject is currently receiving treatment for advanced heart failure.

Multiple Cities, Argentina

Multiple Cities, Australia

Multiple Cities, Brazil

Multiple Cities, Bulgaria

Multiple Cities, Chile

Multiple Cities, Croatia

Multiple Cities, Estonia

Multiple Cities, Guatemala

Multiple Cities, Hungary

Multiple Cities, India

Multiple Cities, Israel

Multiple Cities, Latvia

Multiple Cities, Lithuania

Multiple Cities, Mexico

Multiple Cities, New Zealand

Multiple Cities, Peru

Multiple Cities, Poland

Multiple Cities, Romania

Multiple Cities, Russian Federation

Multiple Cities, Serbia and Montenegro

Multiple Cities, Slovakia

Multiple Cities, South Africa

Multiple Cities, Ukraine

Columbiana, Alabama, United States

Hueytown, Alabama, United States

Huntsville, Alabama, United States

Northport, Alabama, United States

Tucson, Arizona, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Searcy, Arkansas, United States

Foothill Ranch, California, United States

Irvine, California, United States

San Diego, California, United States

San Mateo, California, United States

Santa Monica, California, United States

Jacksonville, Florida, United States

Melbourne, Florida, United States

Miami, Florida, United States

Port Charlotte, Florida, United States

Sebastian, Florida, United States

South Miami, Florida, United States

Winter Haven, Florida, United States

Augusta, Georgia, United States

Barnesville, Georgia, United States

Columbus, Georgia, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Libertyville, Illinois, United States

South Bend, Indiana, United States

Bossier City, Louisiana, United States

Elkton, Maryland, United States

Prince Frederick, Maryland, United States

Towson, Maryland, United States

North Dartmouth, Massachusetts, United States

Bay City, Michigan, United States

Benzonia, Michigan, United States

Portage, Michigan, United States

St Clair Shores, Michigan, United States

Picayune, Mississippi, United States

St Louis, Missouri, United States

Billings, Montana, United States

Las Vegas, Nevada, United States

Elizabeth, New Jersey, United States

Hamilton, New Jersey, United States

Cicero, New York, United States

Charlotte, North Carolina, United States

Mooresville, North Carolina, United States

Franklin, Ohio, United States

Ashland, Oregon, United States

Altoona, Pennsylvania, United States

Fleetwood, Pennsylvania, United States

Harleysville, Pennsylvania, United States

Havertown, Pennsylvania, United States

Norristown, Pennsylvania, United States

Penndel, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Florence, South Carolina, United States

Orangeburg, South Carolina, United States

Taylors, South Carolina, United States

Williamston, South Carolina, United States

Morristown, Tennessee, United States

Arlington, Texas, United States

Colleyville, Texas, United States

Conroe, Texas, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Euless, Texas, United States

Fort Worth, Texas, United States

Garland, Texas, United States

Houston, Texas, United States

Katy, Texas, United States

San Antonio, Texas, United States

Seguin, Texas, United States

Sugarland, Texas, United States

Tomball, Texas, United States

Ogden, Utah, United States

Arlington, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Lewisburg, West Virginia, United States

Milwaukee, Wisconsin, United States

Starting date: September 2006
Last updated: September 12, 2007