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Clinical Trial Details

Trial ID: L5129
Source ID: NCT02221284
Associated Drug: Alogliptin
Title: Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02221284/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin
Outcome Measures: Primary: Percentage of Participants Who Had One or More Adverse 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., Up to Month 12 | 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 final assessment point (up to Month 12) relative to baseline., Baseline, and final assessment point (up to Month 12)|Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%), The reported data were number of participants who achieved specified HbA1c Level (\< 7.0% and \<6.0%) during this study., Baseline, and final assessment point (up to Month 12)|Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level), The reported data were change from baseline in fasting blood glucose level., Baseline, and final assessment point (up to Month 12)|Change From Baseline in Laboratory Test Values (Fasting Insulin Level), The reported data were change from baseline in fasting insulin level., Baseline, and final assessment point (up to Month 12)|Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]), The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance., Baseline, and final assessment point (up to Month 12)|Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β]), The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}., Baseline, and final assessment point (up to Month 12)
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 964
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2014-06-30
Completion Date: 2017-06-30
Results First Posted: 2019-07-19
Last Update Posted: 2019-11-06
Locations: Osaka, Japan|Tokyo, Japan
URL: https://clinicaltrials.gov/show/NCT02221284