Placebo-Controlled Study of the Combination of SYR-322 and Pioglitazone HCl in the Treatment of Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: SYR-322 and pioglitazone HCl (Drug)

Phase: Phase 3

Status: Active, not recruiting

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

Randomized, double-blind, placebo-controlled study dosing with the combination of SYR-322 and pioglitazone HCl as compared to pioglitazone HCl alone, with a 26-week treatment duration.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 and Pioglitazone HCl (ACTOS) in Subjects With Type 2 Diabetes

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: Change in HbA1c at 26 weeks.

Detailed description: The purpose of the study is to evaluate the effect of the combination of SYR-322 with pioglitazone HCl as compared with pioglitazone HCl alone in subjects with type 2 diabetes mellitus who have experienced inadequate glycemic control using metformin 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 and pioglitazone HCl plus metformin, followed by a Follow-Up period.

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,

currently treated with metformin alone but experiencing inadequate glycemic control. The subject should have received metformin for at least the 2 months prior to Randomization.

- The subject has received no treatment with antidiabetic agents other than metformin

within the 2 months prior to Screening.

- The subject has an HbA1c concentration between 8. 0% and 10. 0%, inclusive.

- The subject has a systolic blood pressure less then or equal to 160 mm Hg and a

diastolic pressure less then or equal to 100 mm Hg.

- Female subjects of childbearing potential (i. e., not surgically sterile and/or not

postmenopausal) must be practicing adequate contraception.

- The subject is able and willing to monitor their own blood glucose concentrations with

a home glucose monitor.

Exclusion Criteria:

- 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, Australia

Multiple Cities, Brazil

Multiple Cities, Bulgaria

Multiple Cities, Chile

Multiple Cities, Croatia

Multiple Cities, Estonia

Multiple Cities, Guatemala

Multiple Cities, India

Multiple Cities, Israel

Multiple Cities, Latvia

Multiple Cities, Mexico

Multiple Cities, New Zealand

Multiple Cities, Peru

Multiple Cities, Romania

Multiple Cities, Russian Federation

Multiple Cities, Serbia and Montenegro

Multiple Cities, South Africa

Multiple Cities, Ukraine

Birmingham, Alabama, United States

Columbiana, Alabama, United States

Huntsville, Alabama, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Searcy, Arkansas, United States

Sherwood, Arkansas, United States

Burbank, California, United States

Foothill Ranch, California, United States

Irvine, California, United States

Sacramento, California, United States

San Diego, California, United States

Temecula, California, United States

Tustin, California, United States

Colorado Springs, Colorado, United States

Washington, District of Columbia, United States

Hollywood, Florida, United States

Kissimmee, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Pembroke Pines, Florida, United States

Pinellas Park, Florida, United States

Sarasota, Florida, United States

Vero Beach, Florida, United States

Atlanta, Georgia, United States

Roswell, Georgia, United States

Savannah, Georgia, United States

Warner Robins, Georgia, United States

Chicago, Illinois, United States

Peoria, Illinois, United States

Lafayette, Indiana, United States

South Bend, Indiana, United States

Waterloo, Iowa, United States

Munfordville, Kentucky, United States

Baton Rouge, Louisiana, United States

Marrero, Louisiana, United States

Elkridge, Maryland, United States

Prince Frederick, Maryland, United States

Towson, Maryland, United States

Marlborough, Massachusetts, United States

Ann Arbor, Michigan, United States

Cadillac, Michigan, United States

Detroit, Michigan, United States

Livonia, Michigan, United States

Kansas City, Missouri, United States

North Las Vegas, Nevada, United States

Blackwood, New Jersey, United States

Trenton, New Jersey, United States

New York, New York, United States

Charlotte, North Carolina, United States

Statesville, North Carolina, United States

Gallipolis, Ohio, United States

Marion, Ohio, United States

Clinton, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Allentown, Pennsylvania, United States

Altoona, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Alcoa, Tennessee, United States

Milan, Tennessee, United States

Morristown, Tennessee, United States

Arlington, Texas, United States

Carrollton, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Temple, Texas, United States

Salt Lake City, Utah, United States

Burlington, Vermont, United States

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