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
Background The SARS-CoV-2 Omicron variant, within two months of its detection, replaced the Delta variant to become the dominant circulating variant globally. Therefore, it is essential to understand the characteristics of the disease caused by the variant and its impact on vaccination. Methods A total of 165 confirmed Omicron cases attending a tertiary care hospital in Pune, Maharashtra, between December 2021 to February 2022 were studied. Their demographic, clinical, and immunization history was recorded. Results Among the 165 cases, 7.88% were B.1.1.529 Omicron cases, 25.45% were BA.1 Omicron cases, and 66.67% were BA.2 Omicron cases. Of these 165 patients, 146 (88.48%) were discharged after treatment, 12 (7.27%) died during hospitalization, and seven (4.24%) were brought dead. The presence of one or more comorbid conditions was seen in 15.15%, of which diabetes mellitus and hypertension (28% each) were the most common conditions. Older age (greater than 60 years), an important risk factor for poor outcomes, was present in 9.1% of cases. Among the 165 cases, vaccination with at least one dose of vaccine was found in 80.61% of cases. Out of 165 cases, clinical data was available for 158 cases. Of these 158 cases, 86.71% had symptoms, and 13.29% were asymptomatic. Fever, followed by cough, myalgia, runny nose, and headache, were the most common presenting symptoms. The mean duration of illness was 2.69 days, with 91.14% of cases having the illness for less than five days, and 89.24% of cases had a National Early Warning Score (NEWS) of 1-4, suggesting a good prognosis. In 93.90% of cases, the chest X-ray findings were normal. Of the 158 cases, 92.41% of cases recovered with supportive treatment, and only 7.59% of cases required oxygen therapy. Conclusion The current study shows that the Omicron variant caused mild disease with reduced need for hospital admission and oxygen therapy in India.
