Clinical trial NCT01263496: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2
Diabetes Mellitus
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-12-20
Enrollment: 438
Sex: ALL
Minimum age (years): 29
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Number of Participants With Adverse Events.
timeFrame: 52 Weeks.
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 16).
timeFrame: Baseline and Week 16.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 20).
timeFrame: Baseline and Week 20.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 28).
timeFrame: Baseline and Week 28.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 32).
timeFrame: Baseline and Week 32.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 36).
timeFrame: Baseline and Week 36.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 40).
timeFrame: Baseline and Week 40.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 44).
timeFrame: Baseline and Week 44.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 48).
timeFrame: Baseline and Week 48.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Glycosylated Hemoglobin (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Fasting Plasma Glucose (Week 12).
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Plasma Glucose (Week 16).
timeFrame: Baseline and Week 16.
measure: Change From Baseline in Fasting Plasma Glucose (Week 20).
timeFrame: Baseline and Week 20.
measure: Change From Baseline in Fasting Plasma Glucose (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Fasting Plasma Glucose (Week 28).
timeFrame: Baseline and Week 28.
measure: Change From Baseline in Fasting Plasma Glucose (Week 32).
timeFrame: Baseline and Week 32.
measure: Change From Baseline in Fasting Plasma Glucose (Week 36).
timeFrame: Baseline and Week 36.
measure: Change From Baseline in Fasting Plasma Glucose (Week 40).
timeFrame: Baseline and Week 40.
measure: Change From Baseline in Fasting Plasma Glucose (Week 44).
timeFrame: Baseline and Week 44.
measure: Change From Baseline in Fasting Plasma Glucose (Week 48).
timeFrame: Baseline and Week 48.
measure: Change From Baseline in Fasting Plasma Glucose (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Fasting Plasma Glucose (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Fasting C-peptide (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Fasting C-peptide (Week 16).
timeFrame: Baseline and Week 16.
measure: Change From Baseline in Fasting C-peptide (Week 20).
timeFrame: Baseline and Week 20.
measure: Change From Baseline in Fasting C-peptide (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Fasting C-peptide (Week 28).
timeFrame: Baseline and Week 28.
measure: Change From Baseline in Fasting C-peptide (Week 32).
timeFrame: Baseline and Week 32.
measure: Change From Baseline in Fasting C-peptide (Week 36).
timeFrame: Baseline and Week 36.
measure: Change From Baseline in Fasting C-peptide (Week 40).
timeFrame: Baseline and Week 40.
measure: Change From Baseline in Fasting C-peptide (Week 44).
timeFrame: Baseline and Week 44.
measure: Change From Baseline in Fasting C-peptide (Week 48).
timeFrame: Baseline and Week 48.
measure: Change From Baseline in Fasting C-peptide (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Fasting C-peptide (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
timeFrame: Baseline and Week 12
measure: Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
timeFrame: Baseline and Week 12
measure: Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
Other outcomes:
Locations:
Study officials:
affiliation: Kawasaki Medical School
name: Professor, Department of Medicine
role: STUDY_DIRECTOR
References: