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Clinical Trial Details

Trial ID: L6945
Source ID: NCT01263483
Associated Drug: Alogliptin And Voglibose
Title: Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01263483/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin and voglibose|DRUG: Alogliptin and voglibose|DRUG: Voglibose
Outcome Measures: Primary: 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 or final visit and glycosylated hemoglobin collected at baseline., Baseline and Week 12. | Secondary: Change From Baseline in Glycosylated Hemoglobin (Week 2)., 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 2 and glycosylated hemoglobin collected at baseline., Baseline and Week 2.|Change From Baseline in Glycosylated Hemoglobin (Week 4)., 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 4 and glycosylated hemoglobin collected at baseline., Baseline and Week 4.|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 Fasting Plasma Glucose (Week 2)., The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline., Baseline and Week 2|Change From Baseline in Fasting Plasma Glucose (Week 4)., The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline., Baseline and Week 4.|Change From Baseline in Fasting Plasma Glucose (Week 8)., The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting Plasma Glucose (Week 12)., The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline., Baseline and Week 12.|Change From Baseline in Fasting C-peptide (Week 2)., The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline., Baseline and Week 2.|Change From Baseline in Fasting C-peptide (Week 4)., The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline., Baseline and Week 4.|Change From Baseline in Fasting C-peptide (Week 8)., The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting C-peptide (Week 12)., The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline., Baseline and Week 12.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value)., The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon 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 Meal Tolerance Testing (AUC (0-2))., The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon 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 Insulin Measured by Meal Tolerance Testing (AUC(0-2)., The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon 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 C-peptide Measured by Meal Tolerance Testing (AUC(0-2)., The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon 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 Glucagon Measured by Meal Tolerance Testing (AUC (0-2))., The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Week 12
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 230
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-01
Completion Date: 2008-04
Results First Posted: 2011-07-11
Last Update Posted: 2012-02-03
Locations:
URL: https://clinicaltrials.gov/show/NCT01263483