Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of AD 4833-536 in Subjects With Type 2 Diabetes
The purpose of this study is to determine the safety and tolerability of pioglitazone-azilsartan, once daily (QD), in patients with type 2 diabetes mellitus.
AD-4833-536 is a combination of AD-4833 (pioglitazone) and TAK-536 (azilsartan).
Pioglitazone is an oral antidiabetic agent that acts by reducing insulin resistance and
approved for treatment of adult patients with type 2 diabetes mellitus. Azilsartan is a
angiotensin II receptor blocker that modulates the renin-angiotensin-aldosterone system that
regulates blood pressure. In a recent clinical trial conducted in subjects with moderately
poor to poor control of their type 2 diabetes mellitus, azilsartan coadministered with
pioglitazone showed a reduction in hemoglobin A1C and fasting plasma glucose levels.
After a one week screening period, subjects will be stratified to receive a starting dose of
pioglitazone-azilsartan (30 mg + 20 mg or 45 mg + 20 mg).
The planned open-label treatment period was 52 weeks; however due to formulation issues, the
study was prematurely discontinued and efficacy data were not analyzed.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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