A Study to Evaluate SYR-322 Plus Pioglitazone HCl (ACTOS®) for the Treatment of Subjects With Inadequately Controlled Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: SYR-322, pioglitazone HCl (Drug)

Phase: Phase 3

Status: Recruiting

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

Overall contact:
Laura Rodriguez, Phone: 224-554-5970, Email: lrodriguez@tgrd.com

The purpose of the study is to compare the effect of increasing pioglitazone HCl dose to the effect of adding SYR-322 to the treatment regimen in subjects with inadequate glycemic control while receiving pioglitazone HCl and metformin.

Official title: A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg Versus Dose Titration From 30 mg to 45 mg of Pioglitazone HCl (ACTOS®) in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy

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 addition of SYR-322 versus increasing dose of pioglitazone HCl in subjects with type 2 diabetes mellitus who are inadequately controlled on a combination of metformin and pioglitazone HCl therapy. Subjects will undergo necessary evaluations to determine eligibility for the study during a Screening period, and eligible subjects will participate in a Stabilization period. Randomized subjects will receive treatment with SYR-322 plus pioglitazone HCl placebo or SYR-322 placebo plus pioglitazone HCl (in addition to 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 a historical diagnosis of

type 2 diabetes mellitus.

- The subject’s diabetes is inadequately controlled on a stable dose of metformin plus

pioglitazone HCl.

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

postmenopausal) must be practicing adequate contraception.

Exclusion Criteria:

- The subject has a urine albumin/creatine ratio of greater then 100 µg/mg (113

mg/mmol).

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

within the 6 months prior to Screening.

- The subject has had gastric bypass surgery.

- The subject has New York Heart Association Class III or IV heart failure regardless of

therapy. Currently treated subjects who are stable at class I or II are candidates for the study.

Laura Rodriguez, Phone: 224-554-5970, Email: lrodriguez@tgrd.com

Birmingham, Alabama, United States; Recruiting

Huntsville, Alabama, United States; Recruiting

Lake Havasu City, Arizona, United States; Recruiting

Little Rock, Arkansas, United States; Recruiting

Foothill Ranch, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Los Alamitos, California, United States; Recruiting

Pismo Beach, California, United States; Recruiting

San Diego, California, United States; Recruiting

Golden, Colorado, United States; Recruiting

Clearwater, Florida, United States; Recruiting

Hialeah, Florida, United States; Recruiting

Lakeland, Florida, United States; Recruiting

Marianna, Florida, United States; Recruiting

North Miami Beach, Florida, United States; Recruiting

Pembroke Pines, Florida, United States; Recruiting

Sebastian, Florida, United States; Recruiting

South Miami, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

Winter Park, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Blue Ridge, Georgia, United States; Recruiting

Conyers, Georgia, United States; Recruiting

Decatur, Georgia, United States; Recruiting

Duluth, Georgia, United States; Recruiting

Dunwoody, Georgia, United States; Recruiting

Warner Robins, Georgia, United States; Recruiting

Boise, Idaho, United States; Recruiting

Coeur D'Alene, Idaho, United States; Recruiting

Burr Ridge, Illinois, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Melrose Park, Illinois, United States; Recruiting

Naperville, Illinois, United States; Recruiting

O'Fallon, Illinois, United States; Recruiting

Bloomington, Indiana, United States; Recruiting

Mishawaka, Indiana, United States; Recruiting

Overland Park, Kansas, United States; Recruiting

Marrero, Louisiana, United States; Recruiting

Elkton, Maryland, United States; Recruiting

Rockville, Maryland, United States; Recruiting

Towson, Maryland, United States; Recruiting

Marlborough, Massachusetts, United States; Recruiting

Bay City, Michigan, United States; Recruiting

St. Clair Shores, Michigan, United States; Recruiting

McCook, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Blackwood, New Jersey, United States; Recruiting

Trenton, New Jersey, United States; Recruiting

West Caldwell, New Jersey, United States; Recruiting

Asheboro, North Carolina, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Mooresville, North Carolina, United States; Recruiting

Shelby, North Carolina, United States; Recruiting

Sparta, North Carolina, United States; Recruiting

Bismarck, North Dakota, United States; Recruiting

Orrville, Ohio, United States; Recruiting

Norman, Oklahoma, United States; Recruiting

Ashland, Oregon, United States; Recruiting

Aliquippa, Pennsylvania, United States; Recruiting

Altoona, Pennsylvania, United States; Recruiting

Dawningtown, Pennsylvania, United States; Recruiting

Fleetwood, Pennsylvania, United States; Recruiting

Kingston, Pennsylvania, United States; Recruiting

Norristown, Pennsylvania, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Tipton, Pennsylvania, United States; Recruiting

Florence, South Carolina, United States; Recruiting

Taylors, South Carolina, United States; Recruiting

Williamston, South Carolina, United States; Recruiting

Watertown, South Dakota, United States; Recruiting

Kingsport, Tennessee, United States; Recruiting

Milan, Tennessee, United States; Recruiting

Nashville, Tennessee, United States; Recruiting

Arlington, Texas, United States; Recruiting

Austin, Texas, United States; Recruiting

Colleyville, Texas, United States; Recruiting

El Paso, Texas, United States; Recruiting

Garland, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Hurst, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Seguin, Texas, United States; Recruiting

Hampton, Virginia, United States; Recruiting

Norfolk, Virginia, United States; Recruiting

Richmond, Virginia, United States; Recruiting

Virginia Beach, Virginia, United States; Recruiting

Starting date: December 2006
Ending date: June 2009
Last updated: March 22, 2007