Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Drug Therapy Diabetes Mellitus, Type II Type 2 Diabetes Mellitus Hyperinsulinism Insulin Resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.

Detailed description:
Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system.

In response to this problem, Takeda Global Research \& Development Center, Inc. is developing SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Alogliptin intervention 6: Placebo
Intervention descriptions: intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. intervention 5: Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. intervention 6: Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.

Protocol document: