Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6296
Source ID: NCT01263509
Associated Drug: Alogliptin And Voglibose
Title: Long-term Safety Study 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/NCT01263509/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin and voglibose|DRUG: Alogliptin and voglibose
Outcome Measures: Primary: Number of Participants With Adverse Events., A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below., 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 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 and fasting plasma glucose collected at baseline., Baseline and Week 12.|Change From Baseline in Fasting Plasma Glucose (Week 16)., The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline., Baseline and Week 16.|Change From Baseline in Fasting Plasma Glucose (Week 20)., The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline., Baseline and Week 20.|Change From Baseline in Fasting Plasma Glucose (Week 24)., The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline., Baseline and Week 24.|Change From Baseline in Fasting Plasma Glucose (Week 28)., The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline., Baseline and Week 28.|Change From Baseline in Fasting Plasma Glucose (Week 32)., The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline., Baseline and Week 32.|Change From Baseline in Fasting Plasma Glucose (Week 36)., The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline., Baseline and Week 36.|Change From Baseline in Fasting Plasma Glucose (Week 40)., The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline., Baseline and Week 40.|Change From Baseline in Fasting Plasma Glucose (Week 44)., The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline., Baseline and Week 44.|Change From Baseline in Fasting Plasma Glucose (Week 48)., The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline., Baseline and Week 48.|Change From Baseline in Fasting Plasma Glucose (Week 52)., The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline., Baseline and Week 52.|Change From Baseline in Fasting Plasma Glucose (Final Visit)., The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline., Baseline and Final Visit (up to Week 52).|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 and fasting C-peptide collected at baseline., Baseline and Week 12.|Change From Baseline in Fasting C-peptide (Week 16)., The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline., Baseline and Week 16.|Change From Baseline in Fasting C-peptide (Week 20)., The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline., Baseline and Week 20.|Change From Baseline in Fasting C-peptide (Week 24)., The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline., Baseline and Week 24.|Change From Baseline in Fasting C-peptide (Week 28)., The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline., Baseline and Week 28.|Change From Baseline in Fasting C-peptide (Week 32)., The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline., Baseline and Week 32.|Change From Baseline in Fasting C-peptide (Week 36)., The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline., Baseline and Week 36.|Change From Baseline in Fasting C-peptide (Week 40)., The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline., Baseline and Week 40.|Change From Baseline in Fasting C-peptide (Week 44)., The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline., Baseline and Week 44.|Change From Baseline in Fasting C-peptide (Week 48)., The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline., Baseline and Week 48.|Change From Baseline in Fasting C-peptide (Week 52)., The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline., Baseline and Week 52.|Change From Baseline in Fasting C-peptide (Final Visit)., The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline., Baseline and Final Visit (up to Week 52).|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12)., The change between the value of blood glucose collected at week 12 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 2 hours after the start of the meal., Baseline and Week 12.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24)., The change between the value of blood glucose collected at week 24 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 2 hours after the start of the meal., Baseline and Week 24.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52)., The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal., Baseline and Week 52.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit)., The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal., Baseline and Final Visit (up to Week 52).|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12)., The change between the value of blood glucose collected at week 12 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 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)) (Week 24)., The change between the value of blood glucose collected at week 24 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 2 hours after the start of the meal., Baseline and Week 24.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52)., The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal., Baseline and Week 52.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit)., The change between the value of blood glucose collected at week 52 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 2 hours after the start of the meal., Baseline and Final Visit (up to Week 52).|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12)., The change between the value of insulin collected at week 12 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 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)) (Week 24)., The change between the value of insulin collected at week 24 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 2 hours after the start of the meal., Baseline and Week 24.|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52)., The change between the value of insulin collected at week 52 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 2 hours after the start of the meal., Baseline and Week 52.|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit)., The change between the value of insulin collected at week 52 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 2 hours after the start of the meal., Baseline and Final Visit (up to Week 52).|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12)., The change between the value of C-peptide collected at week 12 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 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)) (Week 24)., The change between the value of C-peptide collected at week 24 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 2 hours after the start of the meal., Baseline and Week 24.|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52)., The change between the value of C-peptide collected at week 52 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 2 hours after the start of the meal., Baseline and Week 52.|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit)., The change between the value of C-peptide collected at week 52 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 2 hours after the start of the meal., Baseline and Final Visit (up to Week 52).|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12)., The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 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)) (Week 24)., The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal., Baseline and Week 24.|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52)., The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal., Baseline and Week 52.|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit)., The change between the value of glucagons collected at week 52 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 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: 179
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-06
Completion Date: 2008-10
Results First Posted: 2011-08-29
Last Update Posted: 2012-02-03
Locations:
URL: https://clinicaltrials.gov/show/NCT01263509