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Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Alogliptin and pioglitazone (Drug); Alogliptin and pioglitazone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Professor, Department of Medicine, Study Director, Affiliation: Department of Medicine, Kawasaki Medical School

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Adverse Events.

Secondary outcome:

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Change From Baseline in Glycosylated Hemoglobin (Week 24).

Change From Baseline in Glycosylated Hemoglobin (Week 28).

Change From Baseline in Glycosylated Hemoglobin (Week 32).

Change From Baseline in Glycosylated Hemoglobin (Week 36).

Change From Baseline in Glycosylated Hemoglobin (Week 40).

Change From Baseline in Glycosylated Hemoglobin (Week 44).

Change From Baseline in Glycosylated Hemoglobin (Week 48).

Change From Baseline in Glycosylated Hemoglobin (Week 52).

Change From Baseline in Glycosylated Hemoglobin (Final Visit).

Change From Baseline in Fasting Blood Glucose (Week 8).

Change From Baseline in Fasting Blood Glucose (Week 12).

Change From Baseline in Fasting Blood Glucose (Week 16).

Change From Baseline in Fasting Blood Glucose (Week 20).

Change From Baseline in Fasting Blood Glucose (Week 24).

Change From Baseline in Fasting Blood Glucose (Week 28).

Change From Baseline in Fasting Blood Glucose (Week 32).

Change From Baseline in Fasting Blood Glucose (Week 36).

Change From Baseline in Fasting Blood Glucose (Week 40).

Change From Baseline in Fasting Blood Glucose (Week 44).

Change From Baseline in Fasting Blood Glucose (Week 48).

Change From Baseline in Fasting Blood Glucose (Week 52).

Change From Baseline in Fasting Blood Glucose (Final Visit).

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).

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

Minimum age: 33 Years. Maximum age: 88 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: May 2008
Last updated: February 1, 2012

Page last updated: August 23, 2015

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