Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
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ClinicalTrials.gov Identifier: NCT00655863 |
Recruitment Status
:
Completed
First Posted
: April 10, 2008
Results First Posted
: May 27, 2013
Last Update Posted
: May 27, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | April 4, 2008 | |||
First Posted Date ICMJE | April 10, 2008 | |||
Results First Submitted Date | February 17, 2013 | |||
Results First Posted Date | May 27, 2013 | |||
Last Update Posted Date | May 27, 2013 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. [ Time Frame: Baseline and Week 16. ] The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
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Original Primary Outcome Measures ICMJE |
To evaluate the change from Baseline in postprandial incremental area under the curve for triglycerides at Week 16. [ Time Frame: 16 weeks ] | |||
Change History | Complete list of historical versions of study NCT00655863 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes. | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes. | |||
Detailed Description | SYR-322 (alogliptin) 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 alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants 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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Eliasson B, Möller-Goede D, Eeg-Olofsson K, Wilson C, Cederholm J, Fleck P, Diamant M, Taskinen MR, Smith U. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia. 2012 Apr;55(4):915-25. doi: 10.1007/s00125-011-2447-3. Epub 2012 Jan 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
71 | |||
Original Estimated Enrollment ICMJE |
75 | |||
Actual Study Completion Date | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands, Sweden | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00655863 | |||
Other Study ID Numbers ICMJE | SYR-322_301 2007-000486-38 ( EudraCT Number ) U1111-1113-2081 ( Registry Identifier: WHO ) NL22649.029.08 ( Registry Identifier: CCMO ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Takeda | |||
Study Sponsor ICMJE | Takeda | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Takeda | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |