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Clinical Trial Details

Trial ID: L6937
Source ID: NCT01318083
Associated Drug: Alogliptin And Glimepiride
Title: Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01318083/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin and glimepiride|DRUG: Alogliptin and glimepiride|DRUG: Glimepiride
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 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 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 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 baseline., Baseline and Week 12.|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 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 12.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT
Phases: PHASE2|PHASE3
Enrollment: 312
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date: 2009-04
Results First Posted: 2011-07-06
Last Update Posted: 2012-02-03
Locations:
URL: https://clinicaltrials.gov/show/NCT01318083