ABSTRACT
Background Type 2 diabetes mellitus (T2DM) patients commonly undergo metformin monotherapy. This study aims to compare the efficacy, safety, and tolerability of combination therapy of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin as add-on therapy in T2DM patients inadequately controlled on metformin. Methodology This was an 18-week, multicenter, randomized, double-blind, active-controlled, parallel-group, phase III clinical study. About 236 participants were randomly assigned to receive either a fixed-dose combination of dapagliflozin 10 mg plus linagliptin 5 mg tablets or a fixed-dose combination of dapagliflozin 10 mg plus vildagliptin SR 100 mg tablets added to metformin monotherapy. The primary outcome was the mean change in hemoglobin A1c (HbA1c) from baseline to the end of week 16. The key secondary endpoints were mean change in postprandial blood glucose (PPBG), fasting blood glucose (FBG), body weight, and the proportion of participants achieving HbA1c less than 7.0%. Results The dapagliflozin/linagliptin combination therapy showed a more significant change in HbA1c from baseline to the end of 16 weeks (mean reduction: -1.59% vs. -1.25%) compared to dapagliflozin/vildagliptin (p < 0.0001). Additionally, compared to the dapagliflozin/vildagliptin group, the dapagliflozin/linagliptin group demonstrated a significant reduction in both PPBG (mean reduction: -59.99 mg/dL vs. -55.34 mg/dL) and FPG (mean reduction: -32.91 mg/dL vs. -26.78 mg/dL). A total of 18 adverse events were reported in 17 (7.20%) participants, all of which were mild and resolved completely. There were no serious adverse events. Conclusions Compared to dapagliflozin and vildagliptin combination therapy, dapagliflozin and linagliptin fixed-dose combination provided clinically significant improvements in glycemic control. Because of its effectiveness, safety, and tolerability, the fixed-dose combination of dapagliflozin and linagliptin was a better option for treating T2DM patients who had previously only received metformin monotherapy.
ABSTRACT
OBJECTIVES: Emerging shreds of evidence indicates that the risk of diabetic foot ulcer and associated morbidity can be reduced through the intensive glycemic control. There are very few studies which assessed the effects of glycemic control on diabetic foot problems among Indian patients. We aimed to assess the effect of glycemic control on the outcomes of diabetic foot problems among adult type 2 diabetes (T2DM) patients with foot ulcers. METHODS: A cross sectional study was conducted among the T2DM patients from a tertiary care teaching hospital in South India. The demographic characters, risk factors, treatment characters, glycemic status were collected among the patients and analyzed against the outcomes of diabetic foot ulcers by reviewing their medical records. Descriptive statistics were used to present the data. The Chi-square test and ANOVA were used for was used for the categorical variables and continuous parameters to identify the factors affecting the outcomes, respectively. All analysis was performed in SPSS v21. RESULTS: Out of the 100 participants included in the study, 70% were male. The majority (78%) were from an age group of 40 to 70 years, and the mean age was found to be 59.91 ± 10.6 years. The mean duration of diabetes was 9.66 years. Only ankle-brachial Index score (p=0.001) was significantly associated with the type of ulcers, whereas other factors not (p>0.05). A high level of average HbA1c, BMI, ABI index and poor glycemic status was associated with a significant debridement strategy and longer duration of hospitalization; however, it was not substantial. CONCLUSION: Our study inferred that poor glycemic status is associated with a significant debridement strategy and longer duration of hospitalization. However, these findings need to be strengthened with adequately powered prospective studies.
