Type 2 Diabetes Mellitus Clinical Trial
Official title:
Multicenter, Randomized, Double Blind, Three-arm Parallel Group Study to Evaluate Efficacy and Safety of Alogliptin and Pioglitazone Combination Therapy on Glucose Control in Type 2 Diabetes Subjects Who Have Inadequate Control With Metformin Monotherapy in Korea
This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 diabetic patients in Korea.
Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell
dysfunction.
Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl
peptidase-4 inhibitor(DPP4I) and thiazolidinediones(TZD) seems reasonable theoretically, for
their effects on different pathophysiologic defects.
Current treatment guidelines recommend a stepwise approach starting with lifestyle
modification or lifestyle modification + metformin monotherapy, with recent focusing on
patient individualization.
In Korea, Korean Diabetes Association also recommends stepwise approach and at the same time,
emphasizes on the initial aggressive treatment including oral combination or insulin therapy
according to HbA1c level to achieve target goal <6.5%.
Guide to the efficacy, timing, options of combination therapy is not clearly defined due to
lack of sufficient evidences yet.
There is no clear report to demonstrate the clinical benefit of initial TZD and DPP4I
combination therapy in the Korean.
Thus it is reasonable to study the effect of combination therapy in the patients with
sub-optimal glucose control with metformin therapy only, comparing various combination
options metformin with DPP4I only, TZD only, or both.
The hypothesis of this study is that combination therapy of alogliptin and pioglitazone added
on the metformin has superior effect on HbA1c reduction than metformin and either alogliptin
or pioglitazone in 6 month treatment.
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