Study of SYR-322 Combined With Metformin in the Treatment of Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: SYR-322 (Drug)

Phase: Phase 3

Status: Recruiting

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

Overall contact:
PPD Call Center, Phone: 877-426-8973

Randomized, double-blind, placebo-controlled study dosing with SYR-322 and metformin compared to placebo and metformin, 26-week treatment duration.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin in Subjects With Type 2 Diabetes

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo 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 and safety of SYR-322 in combination with placebo or metformin in subjects with type 2 diabetes mellitus and 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 or placebo plus metformin, followed by a Follow-Up period. Subjects who complete the study may be eligible for continuing treatment in an open-label extension.

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 3 months prior to Screening

- The subject has received no treatment with antidiabetic agents other than metformin within the 3 months prior to Screening.

- The subject has a HbA1c concentration between 7. 0% and 10. 0%, inclusive.

- The subject has a systolic blood pressure less than or equal to 180 mm Hg and a diastolic pressure less than or equal to 110 mm Hg.

- Female subjects of childbearing potential (ie, 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.

PPD Call Center, Phone: 877-426-8973

Phoenix, Arizona, United States; Recruiting

Anaheim, California, United States; Recruiting

Artesia, California, United States; Recruiting

Fresno, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Mission Viejo, California, United States; Recruiting

Northridge, California, United States; Recruiting

Orange, California, United States; Recruiting

San Diego, California, United States; Recruiting

Walnut Creek, California, United States; Recruiting

Denver, Colorado, United States; Recruiting

Washington, District of Columbia, United States; Recruiting

Cocoa Beach, Florida, United States; Recruiting

Longwood, Florida, United States; Recruiting

Ocala, Florida, United States; Recruiting

Ocoee, Florida, United States; Recruiting

St. Cloud, Florida, United States; Recruiting

Multiple Cities, South Africa; Recruiting

Multiple Cities, Guatemala; Recruiting

Multiple Cities, Chile; Recruiting

Multiple Cities, Argentina; Recruiting

Multiple Cities, Germany; Recruiting

Multiple Cities, Czech Republic; Recruiting

Multiple Cities, Hungary; Recruiting

Multiple Cities, Australia; Recruiting

Multiple Cities, Mexico; Recruiting

Multiple Cities, Poland; Recruiting

Multiple Cities, New Zealand; Recruiting

Multiple Cities, Netherlands; Recruiting

Multiple Cities, Peru; Recruiting

Multiple Cities, India; Recruiting

Multiple Cities, Brazil; Recruiting

Multiple Cities, United Kingdom; Recruiting

Honolulu, Hawaii, United States; Recruiting

Avon, Indiana, United States; Recruiting

Elkhart, Indiana, United States; Recruiting

Evansville, Indiana, United States; Recruiting

St. Louis, Missouri, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Berlin, New Jersey, United States; Recruiting

Burlington, North Carolina, United States; Recruiting

Hickory, North Carolina, United States; Recruiting

Morehead City, North Carolina, United States; Recruiting

Pinehurst, North Carolina, United States; Recruiting

Winston Salem, North Carolina, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Medford, Oregon, United States; Recruiting

Lansdale, Pennsylvania, United States; Recruiting

Charleston, South Carolina, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Simpsonville, South Carolina, United States; Recruiting

Corpus Christi, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Texarkana, Texas, United States; Recruiting

Burlington, Vermont, United States; Recruiting

Starting date: January 2006
Last updated: February 16, 2007