The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Unnamed facility
Okayama, Japan
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.
Time frame: Baseline and Week 12.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose (Week 4).
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Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (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.
Time frame: Baseline and Week 12.
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (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 2 hours after the start of the meal.
Time frame: 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 2 hours after the start of the meal.
Time frame: 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 2 hours after the start of the meal.
Time frame: Baseline and Week 12