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Clinical Trial Details

Trial ID: L5453
Source ID: NCT01945242
Associated Drug: Alogliptin
Title: Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01945242/results
Conditions: Type 2 Diabetes Melitus
Interventions: DRUG: Alogliptin
Outcome Measures: Primary: Number of Participants Reporting One or More Adverse Drug Reactions, Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately., Baseline up to 12 months|Number of Participants Reporting One or More Serious Adverse Drug Reactions, Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately., Baseline up to 12 months | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment., Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|Percentage of Participants of Achieving Objective Glycemic Control, The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0 percent, \<7.0 percent, and \<6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment., Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|Change From Baseline in Fasting Blood Glucose, The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment., Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|Change From Baseline in Fasting Insulin, The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment., Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 1374
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2011-03
Completion Date: 2014-06
Results First Posted: 2016-09-16
Last Update Posted: 2016-09-27
Locations:
URL: https://clinicaltrials.gov/show/NCT01945242