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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: | NCT00755846 |
The purpose of this study is to determine the safety and efficacy of SYR-322 compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: SYR-322 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison Study to Determine the Efficacy and Safety of SYR110322 in Patients With Type 2 Diabetes, Who Are Either Receiving No Current Treatment or Currently Treated With Diet and Exercise, Sulfonylurea, Metformin or a Combination of Sulfonylurea and Metformin |
Enrollment: | 257 |
Study Start Date: | March 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SYR-322
SYR-322 6.25 mg, tablets, orally, once daily for up to 12 weeks
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2: Experimental |
Drug: SYR-322
SYR-322 12.5 mg, tablets, orally, once daily for up to 12 weeks.
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3: Experimental |
Drug: SYR-322
SYR-322 25 mg, tablets, orally, once daily for up to 12 weeks.
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4: Experimental |
Drug: SYR-322
SYR-322 50 mg, tablets, orally, once daily for up to 12 weeks.
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5: Experimental |
Drug: SYR-322
SYR-322 100 mg, tablets, orally, once daily for up to 12 weeks.
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6: Placebo Comparator |
Drug: Placebo
SYR-322 placebo-matching tablets, orally, once daily for up to 12 weeks.
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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, TGRD is developing SYR-322, 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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:
No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following:
Exclusion Criteria:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | SYR-322-003 |
Study First Received: | September 17, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00755846 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetes Mellitus Drug Therapy Diabetes Mellitus, Type II |
Type 2 Diabetes Mellitus Hyperinsulinism Insulin Resistance |
Hyperinsulinism Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Insulin |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |