To Assess the Efficacy and Safety of Fixed-Dose Combination of Teneligliptin and Pioglitazone (Tiban P) in Iraqi Patients with Type 2 Diabetes Mellitus

Abstract

Objective: To assess the efficacy and safety of combination of teneligliptin and pioglitazone on glycemic control in patients with type 2 diabetes mellitus (T2DM) in real-world settings in Iraq. Methods: This was a 3-month, prospective - post-marketing surveillance study to observe the efficacy and safety of dual-drug fixed-dose combination (FDC) of teneligliptin 20 mg and pioglitazone 15 mg (treatment 1 – Tiban P) and teneligliptin 20 mg and pioglitazone 30 mg (treatment 2 – Tiban P) in patients with T2DM in real-world settings in Iraq. Inclusion criteria for patients were –age ≥18 years, diagnosed with T2DM with glycated hemoglobin (HbA1c) ≥ 6.5%, agreed to provide informed consent, and had been prescribed FDC of teneligliptin 20 mg and pioglitazone 15 mg or teneligliptin 20 mg and pioglitazone 30 mg once daily for the management of T2DM. The study exclusion criteria were –patients with type 1 diabetes, severe diabetic complications, severe liver dysfunction, hypersensitivity to any ingredient of the study medications, and those who were pregnant, lactating, or considered ineligible based on the doctor's opinion. Results: A statistically significant reduction (p<0.0001) was observed in HbA1c, fasting blood glucose, and postprandial blood glucose in patients with diabetes being treated with FDC of pioglitazone + teneligliptin. Twelve adverse events (AEs) were noted in 12 patients during the study. No serious AEs or hypoglycemia events were reported in this study. Conclusion: Teneligliptin and pioglitazone combination is effective and safe in managing T2DM in adult Iraqi patients.