OBJECTIVEInsulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the novel basal analog insulin degludec (IDeg: 70%) and insulin aspart (IAsp: 30%). We compared the safety and efficacy of IDegAsp, an alternative formulation (AF) (55% IDeg and 45% IAsp), and insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes inadequately controlled with oral antidiabetic drugs.RESEARCH DESIGN AND METHODSIn this 16-week, open-label trial, subjects (mean age 59.1 years, A1C 8.5%, BMI 30.3 kg/m2) were randomized to once-daily IDegAsp (n = 59), AF (n = 59), or IGlar (n = 60), all in combination with metformin. Insulin was administered before the evening meal and dose-titrated to a fasting plasma glucose (FPG) target of 4.0–6.0 mmol/L.RESULTSAfter 16 weeks, mean A1C decreased in all groups to comparable levels (IDegAsp: 7.0%; AF: 7.2%; IGlar: 7.1%). A similar proportion of subjects achieved A1C <7.0% without confirmed hypoglycemia in the last 4 weeks of treatment (IDegAsp: 51%; AF: 47%; IGlar: 50%). Mean 2-h postdinner plasma glucose increase was lower for IDegAsp (0.13 mmol/L) and AF (0.24 mmol/L) than IGlar (1.63 mmol/L), whereas mean FPG was similar (IDegAsp: 6.8 mmol/L; AF: 7.4 mmol/L; IGlar: 7.0 mmol/L). Hypoglycemia rates were lower for IDegAsp and IGlar than AF (1.2, 0.7, and 2.4 events/patient year). Nocturnal hypoglycemic events occurred rarely for IDegAsp (1 event) and IGlar (3 events) compared with AF (27 events).CONCLUSIONSIn this proof-of-concept trial, once-daily IDegAsp was safe, well tolerated, and provided comparable overall glycemic control to IGlar at similar low rates of hypoglycemia, but better postdinner plasma glucose control.
The in£uence of temperature on the hydraulic properties of unsaturated clays is of major concern in the design of engineered barriers in underground repositories for high-level radioactive waste disposal. This paper presents an experimental study centred on the investigation of the in£uence of temperature on soil hydraulic properties related to water retention and permeability. Laboratory tests were conducted on arti¢cially prepared unsaturated fabrics obtained from a natural kaolinitic-illitic clay. Special attention is given to the testing procedures involving controlled suction and temperature oedometer cells and the application of the vapour equilibrium technique at high temperatures. Retention curves at different temperatures show that total suction tends to reduce with increasing temperatures at constant water content. Temperature in£uence on water permeability is more relevant at low matric suctions corresponding to bulk water preponderance (inter-aggregate zone). Below a degree of saturation of 75% no clear effect is detected. Experimental data show that temperature dependence on permeability at constant degree of saturation and constant void ratio is smaller than what could be expected from the thermal change in water viscosity. This behaviour suggests that phenomena such as porosity redistribution and thermo-chemical interactions, which alter clay fabric and pore £uid, can be relevant.
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