Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263470
• Other study ID #: SYR-322/CCT-001
• Secondary ID: U1111-1118-3752
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2010
• Last updated: February 1, 2012
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).

• A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.

• Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

• Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
• Alogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
• Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
• Alogliptin
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
• Voglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
• Placebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	No
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.	No
Secondary	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.	No
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.	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	Baseline and Week 12.	No
Secondary	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.	Baseline and Week 12	No
Secondary	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.	Baseline and Week 12.	No
Secondary	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.	Baseline and Week 12	No