A COMPARATIVE STUDY TO ASSESS THE SAFETY AND EFFICACY OF SOME ORAL TRIPLE THERAPY REGIMENS IN PATIENTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS

LAVANYA G.; MAKARANDH A.; VENKATESHWARLU E.; SHARAVANABHAVA B. S.; SATHYANARAYANA K.

doi:10.22159/ijpps.2025v17i1.53007

Authors

LAVANYA G. Department of Clinical Pharmacy and Pharm. D., Vaagdevi College of Pharmacy, MGM Hospital, Hanamkonda, Warangal, Telangana, India https://orcid.org/0009-0003-2376-5081
MAKARANDH A. Department of Clinical Pharmacy and Pharm. D., Vaagdevi College of Pharmacy, MGM Hospital, Hanamkonda, Warangal, Telangana, India https://orcid.org/0009-0001-0484-6877
VENKATESHWARLU E. Department of Clinical Pharmacy and Pharm. D., Vaagdevi College of Pharmacy, MGM Hospital, Hanamkonda, Warangal, Telangana, India
SHARAVANABHAVA B. S. Department of Clinical Pharmacy and Pharm. D., Vaagdevi College of Pharmacy, MGM Hospital, Hanamkonda, Warangal, Telangana, India
SATHYANARAYANA K. Satyam’s Diabetes Hospital and Research Centre, Hanamkonda, Warangal, Telangana, India

DOI:

https://doi.org/10.22159/ijpps.2025v17i1.53007

Keywords:

Dapagliflozin, Glimepiride, Gliclazide, Metformin, Sitagliptin, Type 2 diabetes mellitus, Vildagliptin

Abstract

Objective: This study evaluated the safety and efficacy of oral triple therapies (Sitagliptin (S)+Dapagliflozin (D), Vildagliptin (V)+Dapagliflozin (D), Gliclazide (GL)+Vildagliptin (V), Glimepiride (GP)+Vildagliptin (V), Glimepiride (GP)+Voglibose (VG)) as add-ons to Metformin (M) in inadequately controlled Type 2 Diabetes Mellitus (T₂DM) patients on dual therapy.

Methods: This prospective, observational, comparative and multi-centric study was conducted on 813 patients with T₂DM. The effect of therapy on glycaemic control in 813 patients were assessed using appropriate statistical analysis before treatment and at 3 and 6 mo post-treatment.

Results: All the parameters [Glycated Haemoglobin (HbA_1C), Fasting Blood Sugar (FBS) and Post Lunch Blood Sugar (PLBS)] were evaluated before the treatment and reassessed 3 mo and 6 mo after treatment. Average HbA_1C levels at baseline were 8.3±1.23, decreasing to 7.8±1.11 at 3 mo and 7.62±1.01 at 6 mo for M+GL+V, with significant differences (p<0.0017 and p<0.0001). For M+GP+V, HbA_1C decreased from 9.12±0.8 to 8.5±0.7 and 8.1±0.7 (p<0.0001). M+GP+VG showed a reduction from 8.98±0.88 to 8.57±0.82 and 8.17±0.75 (p<0.0001). M+V+D demonstrated a drop from 9.33±0.98 to 7.98±0.80 and 7.13±0.6 (p<0.0001), while M+S+D showed reductions from 9.35±0.67 to 7.77±0.62 and 6.78±0.47 (p<0.0001). FBS and PLBS decreased significantly across all combinations. For M+S+D and M+V+D, the incidence of hypoglycaemia, dizziness, and weight gain was lower compared to other combinations.

Conclusion: M+S+D and M+V+D were most effective in controlling glucose levels, indicating a favourable safety profile and improved glycaemic control in T₂DM patients.

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