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Clinical Trial Details

Trial ID: L3662
Source ID: NCT00957268
Associated Drug: Alogliptin
Title: Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00957268/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Alogliptin
Outcome Measures: Primary: Cmax: Maximum Observed Plasma Concentration for Alogliptin, Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve., 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin, Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax., 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin, AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval in this study)., 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose | Secondary: Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition, The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC\[0-24\]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition, The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition, The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition, The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration, The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC\[0-24\]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration, The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration, The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration, The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration., 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
Start Date: 2009-09
Completion Date: 2013-11
Results First Posted: 2015-01-29
Last Update Posted: 2015-01-29
Locations: Miami, Florida, United States|Pineallas Park, Florida, United States|Louisville, Kentucky, United States|Durham, North Carolina, United States|Philadelphia, Pennsylvania, United States|Memphis, Tennessee, United States|San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT00957268