Clinical trial NCT01318122: Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine 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 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2
Diabetes Mellitus
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 336
Sex: ALL
Minimum age (years): 33
Maximum age (years): 88
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 alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on 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, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).

Eligibility criteria: Inclusion Criteria:

1. Had completed the core phase 2/3 thiazolidine add on study.
2. The subject was capable of understanding and complying with protocol requirements.
3. Signed a written, informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

1. With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
2. With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
3. With a history or symptoms of cardiac failure.

Primary outcomes:
measure: Number of Participants With Adverse Events.
timeFrame: 52 Weeks.
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (Week 8).
timeFrame: Baseline and Week 8.
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 Blood Glucose (Week 8).
timeFrame: Baseline and Week 8.
measure: Change From Baseline in Fasting Blood Glucose (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Fasting Blood Glucose (Week 16).
timeFrame: Baseline and Week 16.
measure: Change From Baseline in Fasting Blood Glucose (Week 20).
timeFrame: Baseline and Week 20.
measure: Change From Baseline in Fasting Blood Glucose (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Fasting Blood Glucose (Week 28).
timeFrame: Baseline and Week 28.
measure: Change From Baseline in Fasting Blood Glucose (Week 32).
timeFrame: Baseline and Week 32.
measure: Change From Baseline in Fasting Blood Glucose (Week 36).
timeFrame: Baseline and Week 36.
measure: Change From Baseline in Fasting Blood Glucose (Week 40).
timeFrame: Baseline and Week 40.
measure: Change From Baseline in Fasting Blood Glucose (Week 44).
timeFrame: Baseline and Week 44.
measure: Change From Baseline in Fasting Blood Glucose (Week 48).
timeFrame: Baseline and Week 48.
measure: Change From Baseline in Fasting Blood Glucose (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Fasting Blood Glucose (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
measure: Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
timeFrame: Baseline and Week 24.
measure: Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
timeFrame: Baseline and Week 52.
measure: Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
timeFrame: Baseline and Final Visit (up to Week 52).
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine, Kawasaki Medical School
name: Professor, Department of Medicine
role: STUDY_DIRECTOR
References: