Anxiety and/or SDS improved significantly in patients included on this study. PC could be an alternative to the use of psychotropic drugs for first intention treatment of anxiety and SDS. Further studies are needed to confirm those results.
Pharmacokinetics oBC Combo showed an earlier onset of appearance (Early t 0.5max ) and higher early PK exposure in the first hour compared with LMx and G+L ( Fig. 1a & Table 2).o BC Combo reached similar maximum concentrations but significantly earlier than both LMx and G+L.
AbstractBC Combo is a co-formulation of prandial insulin lispro (25%) and basal insulin glargine (75%) with a rapid "prandial" insulin component and prolonged flat "basal" component compared to LisproMix (LMx). In this study the effects of BC Combo on PPG vs. LMx and Glargine + Lantus (G+L) were investigated. Thirty-nine T2DM subjects (mean ± SD age 60.8 ± 7.5 years and HbA1c 8.0 ± 0.6 %) received the three insulin combinations immediately before a standardised solid meal test (MMT, 20% protein 30% fat 50% carbohydrates) in a double-blind, double-dummy, randomised crossover design. The individual insulin dose was the same for each visit day (mean 0.62 U/kg). BC Combo improved early PPG compared to LMx (reduction ∆AUC BG_0-2h of 18%, p=0.0009) and G+L (reduction ∆AUC BG_0-2h of 10%, p=0.0450) (primary endpoint). The proportion of subjects experiencing symptomatic hypoglycaemic events (plasma glucose <70 mg/mL) over 24h was lower with BC Combo (15.8%) vs. LMx (32.4%) and G+L (21.6%). The total insulin PK profile of BC Combo showed a faster time to insulin peak and a lower exposure in the late prandial phase (2-6 h) than LMx and G+L. In conclusion, BC Combo demonstrated superior PPG control in T2DM subjects with fewer subjects experiencing symptomatic hypoglycaemia compared to both LMx and separate G+L.
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