Efficacy and Safety of Alogliptin Used 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: Pioglitazone; Drug: Alogliptin and pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318070

SYR-322/CCT-004

U1111-1118-4073 (Registry Identifier)

UMIN000001382 (Registry Identifier)

JapicCTI-080590 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

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.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies.

Enrollment: 339 patients

Sex: All

Ages: 33 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
2. Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
3. Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place).
4. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion criteria

1. Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
2. Had a history or symptoms of cardiac failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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339 participants in 3 patient groups

Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD

Experimental group

Treatment:

Drug: Alogliptin and pioglitazone

Drug: Alogliptin and pioglitazone

Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD

Experimental group

Treatment:

Drug: Alogliptin and pioglitazone

Drug: Alogliptin and pioglitazone

Pioglitazone (15mg or 30mg ) QD

Active Comparator group

Treatment:

Drug: Pioglitazone