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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00286455 |
The purpose of this study is to evaluate the efficacy and safety of SYR-322 in adults with type 2 diabetes.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: SYR-322 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) Compared With Placebo in Subjects With Type 2 Diabetes |
Enrollment: | 328 |
Study Start Date: | February 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SYR-322
SYR-322 12.5 mg, tablets, orally, once daily for up to 26 weeks.
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2: Experimental |
Drug: SYR-322
SYR-322 25 mg, tablets, orally, once daily for up to 26 weeks.
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3: Placebo Comparator |
Drug: SYR-322
SYR-322 placebo-matching tablets, orally, once daily for up to 26 weeks.
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There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are 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.
Takeda is developing SYR-322 for the improvement of glycemic control in patients with type 2 diabetes mellitus. SYR-322 is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.
The aim of the current study is to evaluate the efficacy of SYR-322 in subjects with type 2 diabetes mellitus who are inadequately controlled and who have failed treatment with diet and exercise. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Type 2 diabetes mellitus, experiencing inadequate glycemic control, and are receiving no current antidiabetic therapy. Subjects will qualify if both of the following conditions apply:
Exclusion Criteria
Excluded Medications
Study Director: | VP Biological Sciences | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | SYR-322-PLC-010, 2005-004670-24 |
Study First Received: | February 1, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00286455 |
Health Authority: | United States: Food and Drug Administration |
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes; Diabetes Mellitus |
Lipoatrophic Dyslipidemia Drug Therapy |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias |