Other Clinical Trial - Efficacy & Safety Study of SYR-619 in Treating

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of SYR-619, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.

Clinical Trial Description

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% is type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected, placing an ever increasing burden on families and the health care system.

SYR-619 is an inhibitor of the dipeptidyl peptidase IV enzyme. 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.

The aim of this study is to evaluate the dose-response efficacy, safety and tolerability of treatment with SYR-619 in subjects with type 2 diabetes who do not previously achieve adequate glycemic control with lifestyle modification (diet/exercise) or metformin or sulfonylurea oral antidiabetic monotherapy.

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 fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Diabetes Mellitus

Clinical Trial Details

NCT number	NCT00763347
Study type	Interventional
Source	Takeda
Contact
Status	Terminated
Phase	Phase 2
Start date	November 2006
Completion date	February 2007

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes Mellitus

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms