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

Takeda

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Alogliptin and pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318122

SYR-322/OCT-004

U1111-1119-6207 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 336 patients

Sex: All

Ages: 33 to 88 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD

Active Comparator group

Treatment:

Drug: Alogliptin and pioglitazone

Drug: Alogliptin and pioglitazone

Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD

Active Comparator group

Treatment:

Drug: Alogliptin and pioglitazone

Drug: Alogliptin and pioglitazone