Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy

Exclusion Criteria

• •Participants meeting any of the following criteria will be excluded from enrollment:
• •1. Participants with type 1 diabetes mellitus or secondary forms of diabetes.
• •2. Participants who have been treated with insulin for ≥7 days within 3 months prior to the screening visit.
• •3. Participants with a history of bladder cancer or participants with active bladder cancer.
• •4. Participants with a history of acute diabetic complications such as diabetic ketoacidosis.
• •5. Participants with a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• •6. Participants with unstable or rapidly progressive diabetic retinopathy, nephropathy (estimated glomerular filtration rate \[eGFR\] \<60mL/min/1.73m2).
• •7. Participants with cardiac insufficiency (e.g., a myocardial infarction, a coronary angioplasty or bypass graft, unstable angina, transient ischemic attacks, or a documented cerebrovascular accident within 6 months prior to the screening visit).
• •8. Participants with cardiac failure or history of cardiac failure (New York Heart Association \[NYHA\] Stages 3 to 4).
• •9. Participants with a serum alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice.
• •10. Participants taking concomitant gemfibrozil or other strong cytochrome P450 (CYP)2C8 inhibitors.
• •11. Participants with a history of recurrent or severe hypoglycemia.
• •12. Participants with a history of any hemoglobinopathy (such as hemolytic anemias or sickle cell disease) that may affect determination of HbA1c.
• •13. Participants with uninvestigated microscopic hematuria
• •14. Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since the study drug contains lactose.
• •15. Participants with any other condition judged by the Investigator as unsuitable for the study.
• •16. Participants who have used any investigational or experimental drugs or devices within 60 days of the screening visit.
• •17. Lactating or pregnant female. A positive pregnancy test before the first administration of investigational medicinal product (IMP) or breastfeeding.
• •18. Male participants planning to father during clinical trial conduct or within 3 months after the last planned dose of the IMP.
• •19. Participants were previously enrolled into the current clinical trial.
• •20. The participants participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic effect of the IMP of that clinical trial cannot be excluded.
• •21. Participants are considered unable or unwilling to co-operate adequately, i.e., to follow clinical trial procedures after Investigator has adequately instructed (e.g., language difficulties, etc.) or participants are anticipated not to be available for scheduled clinical trial visits/procedures.