Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea 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 glimepiride; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318083

SYR-322/CCT-005

UMIN000001393 (Registry Identifier)

U1111-1119-6261 (Registry Identifier)

JapicCTI-080626 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) 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 sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite treatment with an sulfonylurea as well as diet and exercise therapies.

Enrollment: 312 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
4. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
5. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion criteria

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 3 patient groups

Alogliptin 12.5 mg QD and Glimepiride QD or BID

Active Comparator group

Treatment:

Drug: Alogliptin and glimepiride

Drug: Alogliptin and glimepiride

Alogliptin 25 mg QD and Glimepiride QD or BID

Active Comparator group

Treatment:

Drug: Alogliptin and glimepiride

Drug: Alogliptin and glimepiride

Glimepiride 1, 2, 3 or 4 mg QD or BID

Active Comparator group

Treatment:

Drug: Glimepiride