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Clinical Trial Details

Trial ID: L5966
Source ID: NCT00655863
Associated Drug: Alogliptin And Pioglitazone
Title: Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00655863/results
Conditions: Diabetes Mellitus
Interventions: DRUG: Alogliptin and Pioglitazone|DRUG: Alogliptin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at 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., Baseline and Week 16. | Secondary: Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4., The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline., Baseline and Week 4.|Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters., The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters., Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline., Baseline, Week 4 and Week 16.|Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1), Postprandial changes over time at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Postprandial Changes Over Time From Baseline for Glucose, Postprandial changes over time at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Postprandial Changes Over Time From Baseline for Insulin, Postprandial changes over time at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Postprandial Changes Over Time From Baseline for Glucagon, Postprandial changes over time at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Glycosylated Hemoglobin, The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline., Baseline, Week 8 and Week 16.|Change From Baseline in Fasting Plasma Glucose, The change in fasting plasma glucose collected at each week indicated relative to baseline., Baseline, Week 4, Week 8 and Week 16.|Change From Baseline in Postprandial C-Peptide, The change in postprandial C-peptide collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Postprandial Proinsulin, The change in postprandial proinsulin collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP), The change in hs-CRP collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Adiponectin, The change in adiponectin collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM), The change in VCAM collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM), The change in ICAM collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in e-Selectin, The change in e-Selectin collected at each week indicated relative to baseline., Baseline, Week 4 and Week 16.|Change From Baseline in Endothelial Function Through Pulse Wave Tonometry, Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment., Baseline and Week 16.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 71
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-07
Completion Date: 2009-12
Results First Posted: 2013-05-27
Last Update Posted: 2013-05-27
Locations: Amsterdam, Netherlands|Gothenburg, Sweden
URL: https://clinicaltrials.gov/show/NCT00655863