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

NCT ID: NCT01318122

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-08-31

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).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD

Group Type: ACTIVE_COMPARATOR

Alogliptin and pioglitazone

Intervention Type: DRUG

Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD

Group Type: ACTIVE_COMPARATOR

Alogliptin and pioglitazone

Intervention Type: DRUG

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Interventions

Alogliptin and pioglitazone

Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Intervention Type: DRUG

Alogliptin and pioglitazone

Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Intervention Type: DRUG

Other Intervention Names

SYR-322; Actos; SYR-322; Actos

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.

• Minimum Eligible Age: 33 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor, Department of Medicine

Role: STUDY_DIRECTOR

Department of Medicine, Kawasaki Medical School

Other Identifiers

U1111-1119-6207

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322/OCT-004

Identifier Type: -

Identifier Source: org_study_id