Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function

Kyunghee University Medical Center96 enrolled

Overview

All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol. * All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks. * Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes

Interventions

NESINA ACT TAB. 25/15mgDRUG

Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.

AMARYL-M TAB. 2/500mgDRUG

Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.

Eligibility

Sex: ALLMin age: 26 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes Mellitus patients * Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy Exclusion Criteria: * The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months * Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks * The use of insulin within the 3 months prior to screening * Others

Locations (1)

Kyunghee University Medical Center

Seoul, South Korea

RECRUITING