Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alogliptin
Alogliptin
Alogliptin
Alogliptin
Voglibose
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion Criteria:
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Alogliptin 6.25 mg QD
Alogliptin 12.5 mg QD
Alogliptin 25 mg QD
Alogliptin 50 mg QD
Voglibose 0.2-mg TID
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01263496
Brief Title
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
Official Title
A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.
Detailed 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, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alogliptin 6.25 mg QD
Arm Type
Experimental
Arm Title
Alogliptin 12.5 mg QD
Arm Type
Experimental
Arm Title
Alogliptin 25 mg QD
Arm Type
Experimental
Arm Title
Alogliptin 50 mg QD
Arm Type
Experimental
Arm Title
Voglibose 0.2-mg TID
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Alogliptin
Other Intervention Name(s)
SYR-322
Intervention Description
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Alogliptin
Other Intervention Name(s)
SYR-322
Intervention Description
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Alogliptin
Other Intervention Name(s)
SYR-322
Intervention Description
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Alogliptin
Other Intervention Name(s)
SYR-322
Intervention Description
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Voglibose
Other Intervention Name(s)
Voglib, BASEN®
Intervention Description
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events.
Description
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.
Time Frame
52 Weeks.
Secondary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Description
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.
Time Frame
Baseline and Week 12.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Description
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.
Time Frame
Baseline and Week 16.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Description
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.
Time Frame
Baseline and Week 20.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 24).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 28).
Description
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.
Time Frame
Baseline and Week 28.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 32).
Description
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.
Time Frame
Baseline and Week 32.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 36).
Description
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.
Time Frame
Baseline and Week 36.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 40).
Description
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.
Time Frame
Baseline and Week 40.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 44).
Description
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.
Time Frame
Baseline and Week 44.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 48).
Description
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.
Time Frame
Baseline and Week 48.
Title
Change From Baseline in Glycosylated Hemoglobin (Week 52).
Description
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.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Description
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.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in Fasting Plasma Glucose (Week 12).
Description
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Fasting Plasma Glucose (Week 16).
Description
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 16.
Title
Change From Baseline in Fasting Plasma Glucose (Week 20).
Description
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 20.
Title
Change From Baseline in Fasting Plasma Glucose (Week 24).
Description
The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Fasting Plasma Glucose (Week 28).
Description
The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 28.
Title
Change From Baseline in Fasting Plasma Glucose (Week 32).
Description
The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 32.
Title
Change From Baseline in Fasting Plasma Glucose (Week 36).
Description
The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 36.
Title
Change From Baseline in Fasting Plasma Glucose (Week 40).
Description
The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 40.
Title
Change From Baseline in Fasting Plasma Glucose (Week 44).
Description
The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 44.
Title
Change From Baseline in Fasting Plasma Glucose (Week 48).
Description
The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 48.
Title
Change From Baseline in Fasting Plasma Glucose (Week 52).
Description
The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Fasting Plasma Glucose (Final Visit).
Description
The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in Fasting C-peptide (Week 12).
Description
The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 12.
Title
Change From Baseline in Fasting C-peptide (Week 16).
Description
The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 16.
Title
Change From Baseline in Fasting C-peptide (Week 20).
Description
The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 20.
Title
Change From Baseline in Fasting C-peptide (Week 24).
Description
The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Fasting C-peptide (Week 28).
Description
The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 28.
Title
Change From Baseline in Fasting C-peptide (Week 32).
Description
The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 32.
Title
Change From Baseline in Fasting C-peptide (Week 36).
Description
The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 36.
Title
Change From Baseline in Fasting C-peptide (Week 40).
Description
The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 40.
Title
Change From Baseline in Fasting C-peptide (Week 44).
Description
The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 44.
Title
Change From Baseline in Fasting C-peptide (Week 48).
Description
The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 48.
Title
Change From Baseline in Fasting C-peptide (Week 52).
Description
The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Fasting C-peptide (Final Visit).
Description
The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
Description
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.
Time Frame
Baseline and Week 12.
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
Description
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.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
Description
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.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
Description
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.
Time Frame
Baseline and Week 12.
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
Description
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.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
Description
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.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
Description
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.
Time Frame
Baseline and Week 12.
Title
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
Description
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.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
Description
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.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
Description
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.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
Description
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.
Time Frame
Baseline and Final Visit (up to Week 52).
Title
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
Description
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.
Time Frame
Baseline and Week 52.
Title
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
Description
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.
Time Frame
Baseline and Final Visit (up to Week 52).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion Criteria:
Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor, Department of Medicine
Organizational Affiliation
Kawasaki Medical School
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
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