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

Dr. S Kumar¹, F. Musharraf², M Jabbar³, T Hussen⁴, U Ubed⁵, N Jardaq⁶, T Alnuaymie⁷, A Karam⁸, B Saisayaq⁹, J Halabja¹⁰, BA Chawsh¹¹, BP Shar¹², D Rzgar¹³, AH Koprlu¹⁴, A Basheer¹⁵, B Ahmed¹⁶, S. Nouraldeen Ali¹⁷, B Haider¹⁸, W Karim¹⁹, S. Salahadeen²⁰, Harishankar Sahu²¹, N Shelar^22
1Pharmcology, Associate Vice President, Medical Affairs, Ajanta Pharma*
²Endocrinologist, Malikat Al Rahma Clinic, Erbil
³Endocrinologist, Diabetes Disease Center, Erbil
⁴Internist, Al Jumhury Hospital, Erbil
⁵Cardiologist, Cardiac Center, Erbil
⁶Internist, Mercy Polyclinic, Erbil
⁷Internist, Al Askari General Hospital, Mosul
⁸Internist, Shar Private Hospital, Sulaymaniyah
⁹Internist, Al Sadiq General hospital, Sulaymaniyah
¹⁰Internist, Halabja General Hospital, Branch of Diabetic & Metabolism
¹¹Internist, College of Medicine, University of Sulaymaniyah
¹² Internist, Shar Private Hospital, Sulaymaniyah
¹³Internist, Hawlati Polyclinic, Branch of Diabetic & Metabolism
¹⁴Internist, College of Medicine, Azady Hospital
¹⁵Internist, Qaiwan International University
¹⁶Internist, Al Qasa General Hospital
¹⁷Internist, Azadi Teaching Hospital, Branch of Diabetic & Metabolism
¹⁸Internist, Nawroz Private Hospital, Duhok
¹⁹Internist, College of Medicine, Garmian University
²⁰Internist, Al Masa General Hospital Azady Hospital
²¹Group Product Manager, Ajanta Pharma Limited, Mumbai
²²Sr Marketing Manager, Ajanta Pharma Limited, Mumbai

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.
Keywords: Diabetes, Fasting blood glucose, Glycated hemoglobin, Pioglitazone, Teneligliptin

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