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Clinical Trial Details

Trial ID: L6766
Source ID: NCT01449747
Associated Drug: Sitagliptin
Title: Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01449747/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin
Outcome Measures: Primary: Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment, Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test., 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment, Plasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test., 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment, Plasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test., 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment, Plasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin., 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose | Secondary: Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups, The DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100., 0, 15, 30, 45, 60 min post-dose
Sponsor/Collaborators: Sponsor: The Catholic University of Korea | Collaborators: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12
Completion Date: 2015-07
Results First Posted: 2015-12-14
Last Update Posted: 2015-12-14
Locations: The Catholic University of Korea; St.Paul's Hospital, Seoul, 130-709, Korea, Republic of|The Catholic University of Korea; Seoul St. Mary's Hospital, Seoul, 137-701, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01449747