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

Kyung Hee University

Status and phase: Unknown; Phase 4

Conditions: Diabetes

Treatments: Drug: AMARYL-M TAB. 2/500mg; Drug: NESINA ACT TAB. 25/15mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02823808

KNDP_IIT_2016_01

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 26 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups

ALO+PIO

Experimental group

Description:

Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily.

Treatment:

Drug: NESINA ACT TAB. 25/15mg

GMPD+MET

Active Comparator group

Description:

Group who takes Glimepiride 2mg+Metformin 500mg, once daily.

Treatment:

Drug: AMARYL-M TAB. 2/500mg