AimsTo conduct a patient-level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes (T2DM) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively.MethodsThe EDITION studies were multicentre, randomized, open-label, parallel-group, phase IIIa studies, with similar designs and endpoints. A patient-level meta-analysis of the studies enabled these endpoints to be examined over 6 months in a large population with T2DM (Gla-300, n = 1247; Gla-100, n = 1249).ResultsNo significant study-by-treatment interactions across studies were found, enabling them to be pooled. The mean change in glycated haemoglobin was comparable for Gla-300 and Gla-100 [each −1.02 (standard error 0.03)%; least squares (LS) mean difference 0.00 (95% confidence interval (CI) −0.08 to 0.07)%]. Annualized rates of confirmed (≤3.9 mmol/l) or severe hypoglycaemia were lower with Gla-300 than with Gla-100 during the night (31% difference in rate ratio over 6 months) and at any time (24 h, 14% difference). Consistent reductions were observed in percentage of participants with ≥1 hypoglycaemic event. Severe hypoglycaemia at any time (24 h) was rare (Gla-300: 2.3%; Gla-100: 2.6%). Weight gain was low (<1 kg) in both groups, with less gain with Gla-300 [LS mean difference −0.28 kg (95% CI −0.55 to −0.01); p = 0.039]. Both treatments were well tolerated, with similar rates of adverse events.ConclusionGla-300 provides comparable glycaemic control to Gla-100 in a large population with a broad clinical spectrum of T2DM, with consistently less hypoglycaemia at any time of day and less nocturnal hypoglycaemia.

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Smaller sheaths, radial access, and timely sheath removal may mitigate the bleeding risk associated with potent antithrombotic/platelet therapy and early catheterization.

BCG is a stable, ready-to-inject, aqueous formulation of human glucagon for hypoglycemia rescue therapy. In this randomized, double-blind, crossover trial we investigated the safety and efficacy of two BCG formulations vs. a commercially available glucagon (GlucaGen® HypoKit, GEN) in 27 patients with type 1 diabetes who received single subcutaneous doses of 1 mg of BCG1, BCG2 or GEN under insulin-induced hypoglycemic conditions (plasma glucose (PG)&lt;60 mg/dl). Both BCG formulations were safe and well tolerated with the most frequent adverse event being mild nausea with both BCGs and GEN. Both BCGs quickly restored PG of ≥ 70 mg/dl after hypoglycemia (BCG1 11.5±5.0 min; BCG2 10.0±3.5 min; GEN 7.3±1.8 min, p&lt;0.001 vs. BCG1 and BCG2). PG≥70 mg/dl was reached within 30 minutes by all but one patient with both BCGs and the mean PG increase at 15 minutes was 29±17 mg/dl with BCG1, 36±16 mg/dl with BCG2 and 47±11 mg/dl with GEN (p&lt;0.001 vs. BCG1 and BCG2). In conclusion, the BioChaperone technology allows the formulation of stable ready-to-use liquid formulations of human glucagon suited for rescue therapy of severe hypoglycemia with only slightly slower effects than GEN. Disclosure S. Glezer: Stock/Shareholder; Self; Sanofi. Stock/Shareholder; Spouse/Partner; Sanofi. Employee; Self; ADOCIA, Novo Nordisk Inc.. Employee; Spouse/Partner; Pfizer Inc., Teva Pharmaceutical Industries Ltd.. Stock/Shareholder; Spouse/Partner; Teva Pharmaceutical Industries Ltd.. U. Hovelmann: None. S. Teng: Employee; Self; ADOCIA. D. Lamers: None. M. Odoul: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. J. Correia: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. E. Zijlstra: Speaker's Bureau; Self; Novo Nordisk A/S. Other Relationship; Self; Novo Nordisk A/S. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. D. Duracher: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA.

Glezer (2020) User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a staked 8 mm ultra-thin wall needle,