Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

Takeda

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Voglibose; Drug: Placebo; Drug: Alogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263470

U1111-1118-3752 (Registry Identifier)

SYR-322/CCT-001

Details and patient eligibility

About

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

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 could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Enrollment: 480 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
• A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
• Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion criteria

• Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Alogliptin 6.25 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Alogliptin 12.5 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Alogliptin 25 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Alogliptin 50 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Voglibose 0.2 mg TID

Active Comparator group

Treatment:

Drug: Voglibose