To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basalbolus regimen. RESEARCH DESIGN AND METHODS This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart (n 5 546) or IAsp (n 5 545). All available information, regardless of treatment discontinuation or use of ancillary treatment, was used for evaluation of effect. RESULTS Noninferiority for the change from baseline in HbA 1c 16 weeks after randomization (primary end point) was confirmed for faster aspart versus IAsp (estimated treatment difference [ETD] 20.04% [95% CI 20.11; 0.03]; 20.39 mmol/mol [21.15; 0.37]; P < 0.001). Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD 20.40 mmol/L [20.66; 20.14]; 27.23 mg/dL [211.92; 22.55]; P 5 0.001 for superiority). Change from baseline in self-measured 1-h PPG increment for the mean over all meals favored faster aspart (ETD 20.25 mmol/L [20.42; 20.09]); 24.58 mg/dL [27.59; 21.57]; P 5 0.003). The overall rate of treatment-emergent severe or blood glucose (BG)confirmed hypoglycemia was statistically significantly lower for faster aspart versus IAsp (estimated treatment ratio 0.81 [95% CI 0.68; 0.97]). CONCLUSIONS In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.
The present study was performed to explore the effect of aqueous extract of Aloe vera on behavioural parameters of pain. Pain assessment was performed by the tail-flick and formalin tests. A. vera (100 mg/kg, per oral (p.o.)) produced an insignificant decrease in the pain response in the tail-flick and formalin tests. Moreover, A. vera (200 and 400 mg/kg, p.o.) did not have significant effect on the tail-flick test. However, A. vera (200 and 400 mg/kg, p.o.) significantly decreased the second phase of the formalin-induced pain. Thus, these findings suggest that A. vera exerts its effect by a peripheral mechanism of action rather than central.
Melatonin is an important modulator of nervous system functioning and important neural antioxidant. Organophosphate pesticides like phosphamidon (PHOS) have been shown to adversely affect memory and induce oxidative stress on both acute and chronic exposure. This study was designed to explore the modulation of the effects of PHOS on cognitive function by melatonin (MEL). Cognitive function was assessed using step-down latency (SDL) on a passive avoidance apparatus and transfer latency (TL) on an elevated plus maze. Oxidative stress was assessed by examining the levels of malondialdehyde (MDA) and nonprotein thiols (NP-SH) in isolated homogenized whole brain samples. The results showed a significant reduction in SDL and prolongation of TL in the PHOS (1.74 mg/kg/day; p.o.)-treated group at weeks 6 and 8 as compared to the control group. Two-week treatment with MEL (5 mg/kg/day; i.p.) antagonized the effect of PHOS on SDL as well as TL. PHOS alone produced a significant increase in the brain MDA levels and decrease in the brain NP-SH levels. Treatment with MEL attenuated the effect of PHOS on oxidative stress. Together the results showed that MEL attenuated the cognitive dysfunction and decreased oxidative stress induced by PHOS in the brain.
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