Background: Insulin gargine 300U/mL (Gla-300) forms a more compact subcutaneous depot with a reduced surface area compared to Gla-100, determining a lower re-dissolution rate. Methods: We report the main evidences from clinical studies and meta-analyses to compare PK/PD and clinical profile of Gla-300 vs Gla-100 in Diabetes Mellitus (DM). Results: Two Gla-300 PK/PD studies demostrate a more prolonged glycemic control and even activity with a lower within-/between-day intra-subject variability in exposure vs Gla-100. Consistent data emerge from a study comparing the two glycemic profile by Continuous-Glucose-Monitoring in Type1DM. A patient-level metana-analysis of 1-year data of the EDITION studies in Type2DM, comparing efficacy and safety of Gla-300 vs -100, demostrated a more sustained glycemic control in both groups and a higher A1c reduction for Gla-300 at 12 months: least squares (LS) meas change from baseline to month 12 was -0.91 (SE 0.03)% with Gla-300 and -0.8 (0.03)% with Gla-100. The LS mean difference for change in A1c between the groups was statistically significant. Fewer partecipants experienced &ge1 confirmed (&le3.9mmoL/L) or severe hypoglycemic event during the night (00:00-05:59h) (RR 0.85;95%CI: 0.77,0.92) and at any time of day (RR 0.94;95%CI: 0.9,0.98) with Gla-300 vs Gla-100. The annualized rates of hypoglycemia during the night were lower with Gla-300 vs Gla-100. The benefit of Gla-300 was seen during the night and beyond the pre-defined nocturnal period, for both the partecipants experiencing &ge1 confirmed or severe event and events/partecipant-year. These benefits are confirmed by a retrospective observational study in real-life regarding 881 patients with Type2DM switching to Gla-300 from other basal insulins: mean reduction in A1c levels from basline to follow-up (0-6 months) was 0.64% (8.97% vs 8.33%;95%CI: 0.45,0.84;P<0.0001). The reduction in A1c levels was seen as early as the first 3 months following Gla-300 initiation. Switching to Gla-300 from other basal insulins was associated with a 0.9% reduction in the subjects with hypoglycemia from baseline to follow-up (0-3 months) (6% vs 5.1%). Conclusions: Gla-300, due to a more compact depot, is associated with a more stable and prolonged PK/PD profile and a sustained glycemic control with a lower risk of hypoglycemia than Gla-100.

Henna (Lawsonia inermis L.) tattooing has been used in Egypt and India since ancient times. Today this temporary body art is becoming increasingly popular among young people. Various chemicals are added to henna to darken and enhance the definition of tattoos, especially para-phenylenediamine (PPD), which is a strong sensitizer known to cause cross sensitive reactions to azoic dyes and other para-amino compounds. We present the case of an 18-year-old girl who became clinically sensitive to textile dyes after having showed a serious reaction both to her first hair dying when she was 16 years old and following the application of a temporary henna tattoo when she was a kid. The evidence from our literature review showed 33 cases of manifest sensitization to hair dye and only one of observable contact allergy to both hair and textile dyes from henna tattoos. The sensitization of children may have long-life lasting consequences, because of cross-reaction to dyes and other chemicals contained in hair colourants, clothes and drugs. Since tattoos are very popular and globalization has increased the circulation of unauthorized products we point out the need for informative campaigns about the risk of sensitization caused by temporary tattoos.