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
CONTEXT: To find a single time point during clonidine stimulation test (CST), with highest diagnostic value to rule out growth hormone deficiency (GHD). SETTINGS AND DESIGN: This is a retrospective study of 79 CSTs carried out in a tertiary care center in India. MATERIALS AND METHODS: A cohort of 79 children with unexplained short stature was divided into two groups: GHD and non-GHD. Any one stimulated growth hormone (GH) level >10 ng/mL was used to rule out GHD. Diagnostic accuracy of not only single time points but also time points in pairs was calculated. STATISTICAL ANALYSIS: The data were analyzed using SPSS statistical software 22.0. Descriptive statistics were used for analyzing demographic data. Mode for time to peak GH was calculated in each group. The specificity and false positive rates at each time point as well as combined time points were determined. RESULTS: Assaying a single sample at 60 min after clonidine resulted in 20.5% false positive tests with specificity of 79.5%. Addition of the 90 min sample increased specificity to 92.3%. CONCLUSION: The 60 min sample after clonidine stimulation was the best single sample to rule out GH deficiency. Combined sampling at 60 min + 90 min is economical and less cumbersome, with minimal compromise on the specificity.
