Randomized trial assessed HbA1c and lipid profile changes in type II diabetes, suggesting similar outcomes for both treatments.
Objective: To compare the outcome of combination of vildagliptin with metformin empagliflozin with metformin in individuals diagnosed with type II diabetes mellitus Study design: Randomized controlled trial. Place and duration of study: Department of Medicine, AIMS, Muzaffarabad, AJK from 21 January, 2025 to 15 June, 2025. Methodology: Three hundred and twenty individuals, fulfilled the selection criteria, were included. Then individuals were randomly allocated in 02 groups. In group-A, individuals were prescribed once daily oral empagliflozin plus metformin at the dose of 10/1000 mg. In group-B, individuals were prescribed once daily oral vildagliptin plus metformin at the dose of 50/1000 mg. At baseline and after 12 weeks of follow-up, HbA1c, fasting blood glucose level and lipid profile were assessed. Data was analyzed in SPSS v.25.0, with P–value ≤ 0.05 as significant. Results: In this trial, we enrolled total 320 individuals and randomized them in two equal group. The mean age of individuals enrolled in Group-A was 56.16 ± 9.57 years as well as in Group-B was 57.86 ± 9.33 years. In Group-A, there were 94 (58.8%) men and 66 (41.3%) women. In Group-B, there were 79 (49.4%) men and 81 (50.6%) women. The median change in HBA1c level in Group-A that was 0.80 (IQR: 0.78) % and in Group-B was 1.00 (IQR: 0.80) %. The median change in HBA1 was more achieve in Group-B, however the difference was insignificant (p>0.05). In Group-A, the median change in fasting blood glucose level of 20.00 (IQR: 37.50) vs. 25.00 (IQR: 46.75) mg/dl (p>0.05). The median change in total cholesterol level was 20.00 (IQR: 38.00) mg/dl vs. 28.00 (IQR: 31.00) mg/dl (p<0.05) and median change in triglycerides level was 28.00 (IQR: 40.00) vs. 29.00 (IQR: 79.00) mg/dl (p>0.05). Conclusion: The change in glycemic level and lipid profile of diabetic individuals is similar whether vildagliptin is given or empagliflozin is given in combination with metformin.
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Haroon et al. (2025) studied this question.
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