Efficacy of SYR-472 in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

Key facts

Study ID

NCT00653185

Run by

Takeda

People needed

369

Starts

2007-05-01

Expected to finish

2008-03-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a historical diagnosis of type 2 diabetes mellitus.
• Has undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
• The subject receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run-in/Stabilization Period as determined by subject diary and investigator assessment.
• Has received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening.
• Has a glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
• The subject's fasting C-peptide concentration is greater than or equal to 0.8 ng/mL.
• Has a fasting plasma glucose concentration less than 275 mg/dL.
• If regularly uses other non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
• Has a systolic blood pressure reading less than 160 mm Hg and a diastolic pressure reading less than 100 mm Hg.
• Has a hemoglobin value greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
• Has an alanine aminotransferase level is less than or equal to 3 times the upper limit of normal.
• Males have a serum creatinine value less than 1.5 mg/dL; females have a serum creatinine value less than 1.4 mg/dL.
• Has a urine albumin/creatinine ratio less than 1000 μg/mg.
• Has a thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and is clinically euthyroid.
• Females must be not be pregnant or lactating, and must agree to use adequate contraception throughout the duration of the study.
• Is able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
• Has no major illness or debility that in the investigator's opinion prohibits the subject from completing the study.

You may not qualify if…

• Is being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
• Has a history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening.
• Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• Has a history of treated diabetic gastric paresis.
• Has New York Heart Association class III or IV heart failure regardless of therapy.
• Has a history of coronary angioplasty, underwent coronary stent placement or coronary bypass surgery, or suffered a myocardial infarction, or stroke within the 6 months prior to Screening.
• Has a history of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• Has a history of infection with human immunodeficiency virus.
• Has a history of a psychiatric disorder that in the investigator's opinion will affect the subject's ability to participate in the study.
• Has ingested or received systemically injected glucocorticoids within the 3 months prior to randomization. Inhaled corticosteroids are allowed.
• Has used prescription or over-the-counter weight-loss drugs within the 3 months prior to randomization.
• Has received any investigational drug within the 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
• Has received previous treatment in an investigational study of SYR-472.
• Has a known hypersensitivity to any compound related to SYR-472.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Pell City, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — National City, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Clearwater, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Ocoee, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Dawsonville, Georgia, United States
• Study site — Gainesville, Georgia, United States
• Study site — Naperville, Illinois, United States
• Study site — Elkhart, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Slidell, Louisiana, United States
• Study site — Taunton, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Great Falls, Montana, United States
• Study site — Scottsbluff, Nebraska, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.