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Clinical Trial Details

Trial ID: L3480
Source ID: NCT01318122
Associated Drug: Alogliptin And Pioglitazone
Title: Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01318122/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin and pioglitazone|DRUG: Alogliptin and pioglitazone
Outcome Measures: Primary: Number of Participants With Adverse Events., Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing., 52 Weeks. | Secondary: Change From Baseline in Glycosylated Hemoglobin (Week 8)., 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 week 8 and glycosylated hemoglobin collected at baseline., Baseline and Week 8.|Change From Baseline in Glycosylated Hemoglobin (Week 12)., 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 week 12 and glycosylated hemoglobin collected at baseline., Baseline and Week 12.|Change From Baseline in Glycosylated Hemoglobin (Week 16)., 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 week 16 and glycosylated hemoglobin collected at baseline., Baseline and Week 16.|Change From Baseline in Glycosylated Hemoglobin (Week 20)., 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 week 20 and glycosylated hemoglobin collected at baseline., Baseline and Week 20.|Change From Baseline in Glycosylated Hemoglobin (Week 24)., 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 week 24 and glycosylated hemoglobin collected at baseline., Baseline and Week 24.|Change From Baseline in Glycosylated Hemoglobin (Week 28)., 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 week 28 and glycosylated hemoglobin collected at baseline., Baseline and Week 28.|Change From Baseline in Glycosylated Hemoglobin (Week 32)., 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 week 32 and glycosylated hemoglobin collected at baseline., Baseline and Week 32.|Change From Baseline in Glycosylated Hemoglobin (Week 36)., 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 week 36 and glycosylated hemoglobin collected at baseline., Baseline and Week 36.|Change From Baseline in Glycosylated Hemoglobin (Week 40)., 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 week 40 and glycosylated hemoglobin collected at baseline., Baseline and Week 40.|Change From Baseline in Glycosylated Hemoglobin (Week 44)., 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 week 44 and glycosylated hemoglobin collected at baseline., Baseline and Week 44.|Change From Baseline in Glycosylated Hemoglobin (Week 48)., 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 week 48 and glycosylated hemoglobin collected at baseline., Baseline and Week 48.|Change From Baseline in Glycosylated Hemoglobin (Week 52)., 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 week 52 and glycosylated hemoglobin collected at baseline., Baseline and Week 52.|Change From Baseline in Glycosylated Hemoglobin (Final Visit)., 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 week 52 or final visit and glycosylated hemoglobin collected at baseline., Baseline and Final Visit (up to Week 52).|Change From Baseline in Fasting Blood Glucose (Week 8)., The change between the value of fasting blood glucose collected at week 8 and baseline., Baseline and Week 8.|Change From Baseline in Fasting Blood Glucose (Week 12)., The change between the value of fasting blood glucose collected at week 12 and baseline., Baseline and Week 12.|Change From Baseline in Fasting Blood Glucose (Week 16)., The change between the value of fasting blood glucose collected at week 6 and baseline., Baseline and Week 16.|Change From Baseline in Fasting Blood Glucose (Week 20)., The change between the value of fasting blood glucose collected at week 20 and baseline., Baseline and Week 20.|Change From Baseline in Fasting Blood Glucose (Week 24)., The change between the value of fasting blood glucose collected at week 24 and baseline., Baseline and Week 24.|Change From Baseline in Fasting Blood Glucose (Week 28)., The change between the value of fasting blood glucose collected at week 28 and baseline., Baseline and Week 28.|Change From Baseline in Fasting Blood Glucose (Week 32)., The change between the value of fasting blood glucose collected at week 32 and baseline., Baseline and Week 32.|Change From Baseline in Fasting Blood Glucose (Week 36)., The change between the value of fasting blood glucose collected at week 36 and baseline., Baseline and Week 36.|Change From Baseline in Fasting Blood Glucose (Week 40)., The change between the value of fasting blood glucose collected at week 40 and baseline., Baseline and Week 40.|Change From Baseline in Fasting Blood Glucose (Week 44)., The change between the value of fasting blood glucose collected at week 44 and baseline., Baseline and Week 44.|Change From Baseline in Fasting Blood Glucose (Week 48)., The change between the value of fasting blood glucose collected at week 48 and baseline., Baseline and Week 48.|Change From Baseline in Fasting Blood Glucose (Week 52)., The change between the value of fasting blood glucose collected at week 52 and baseline., Baseline and Week 52.|Change From Baseline in Fasting Blood Glucose (Final Visit)., The change between the value of fasting blood glucose collected at week 52 or final visit and baseline., Baseline and Final Visit (up to Week 52).|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12)., The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Week 12.|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24)., The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Week 24.|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52)., The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Week 52.|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit)., The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Final Visit (up to Week 52).
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 336
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-05
Completion Date: 2009-08
Results First Posted: 2011-09-02
Last Update Posted: 2012-02-03
Locations:
URL: https://clinicaltrials.gov/show/NCT01318122