Diabetes Mellitus, Type 2 Clinical Trial
Official title:
An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients
Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.
PEAK trial is now undergoing (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, Takeda No. ALO-IIT-012).
Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety
of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.
Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.
PEAK trial will be followed by another 28 week open-label treatment of the same drug as
initial randomization (total duration of treatment as randomized 52 week), and followed by 2
year of observation.
During observation period, any antidiabetic medication can be added/changed when HbA1c of the
subject is off target 7% with clinician's clinical decision.
After 3 years of initial randomization, durability of glucose control will be assessed
between 3 treatment group.
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