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Sponsored by: |
Takeda Global Research & Development Centre (Europe) Ltd. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00655863 |
The purpose of this study is to compare the efficacy of SYR-322 taken by itself and with pioglitazone on lipid measures in type 2 diabetes subjects after eating.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: SYR-322 and pioglitazone Drug: SYR-322 Drug: Pioglitazone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes |
Estimated Enrollment: | 75 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SYR-322 and pioglitazone
SYR-322 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
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2: Experimental |
Drug: SYR-322
SYR-322 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
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3: Placebo Comparator |
Drug: Pioglitazone
SYR-322 placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
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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 healthcare system. A recent review of results from 2 National Health and Nutritional Examination surveys conducted in the United States found that, despite the introduction of new classes of medications for glycemic control, the percentage of adults with diabetes mellitus achieving a glycosylated hemoglobin level of less than 7% (a goal set by the American Diabetes Association) has remained relatively unchanged when data from 1999 to 2000 were compared from data from 1988 to 1994. This percentage has remained high, despite compelling evidence from a United Kingdom Prospective Diabetes Study showing that a dramatic reduction in microvascular complications and cardiovascular complications occurred when the glycosylated hemoglobin target level was indeed achieved. The rising incidence of type 2 diabetes mellitus and the limitations of the currently available treatments suggest the need for new therapies for glycemic control.
SYR-322 is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.
Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.
This study will assess the effects of SYR-322 and SYR-322 coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in subjects with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Excluded Medications:
Contact: Takeda Study Registration Call Center | 800-778-2860 |
Netherlands | |
Recruiting | |
Amsterdam, Netherlands | |
Sweden | |
Recruiting | |
Gothenburg, Sweden |
Study Director: | Medical Director | Takeda Global Research & Development Centre (Europe) Ltd. |
Responsible Party: | Takeda Global Research & Development Centre (Europe) Ltd. ( VP, Clinical Science ) |
Study ID Numbers: | SYR-322_301, 2007-000486-38 |
Study First Received: | April 4, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00655863 |
Health Authority: | United States: Food and Drug Administration; Sweden: Regional Ethical Review Board; Sweden: Medical Products Agency; Netherlands: Medical Ethics Review Committee (METC) |
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes |
Diabetes Mellitus Lipoatrophic; Dyslipidemia Drug Therapy |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |