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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function After Early Intensive Diabetes Treatment

Conditions
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Diabetes

Intervention / Treatment
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* Drug: NESINA ACT TAB. 25/15mg
* Drug: AMARYL-M TAB. 2/500mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALO+PIO<br>Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily. | Drug: NESINA ACT TAB. 25/15mg<br>* Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.<br>|
| Active Comparator: GMPD+MET<br>Group who takes Glimepiride 2mg+Metformin 500mg, once daily. | Drug: AMARYL-M TAB. 2/500mg<br>* Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control |  | 104 weeks from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 104 weeks from randomization | 
| Change in Fasting Blood Sugar |  | 104 weeks from randomization | 
| Change in Glycoalbumin |  | 104 weeks from randomization | 
| Change in insulin sensitivity (HOMA2%S) |  | 104 weeks from randomization | 
| Change in insulin sensitivity (HOMA2%B) |  | 104 weeks from randomization | 
| Change in proinsulin |  | 104 weeks from randomization | 
| Change in glucagon |  | 104 weeks from randomization |