Aim: To compare the safety, pharmacokinetics and pharmacodynamics of ADO09 with insulin lispro (Lispro) and separate subcutaneous injections of human insulin and pramlintide (Ins&Pram) in 24 subjects with type 1 diabetes.
Methods: At three dosing visits, participants received single doses of ADO09, Ins&Pram or Lispro immediately before eating a standardized mixed meal together with 1 g of acetaminophen, which was used as a surrogate marker to evaluate the kinetics of gastric emptying. Premeal blood glucose was adjusted to 126 mg/dL ± 10% by means of insulin and glucose infusions.
We investigated the pharmacodynamics (PD) and pharmacokinetics (PK) of BioChaperone insulin Lispro (BCLIS), faster insulin aspart (FIA) and insulin aspart (ASP) in patients with type 1 diabetes using an insulin pump. In this randomized, double-blind, three-way crossover glucose clamp study, 43 patients received a bolus dose of each insulin (0.15 U/kg) in addition to a basal rate (0.
View Article and Find Full Text PDFAim: To investigate the safety and efficacy of BioChaperone Lispo (BCLIS), an ultra-rapid formulation of insulin lispro (LIS) in people with type 1 diabetes.
Materials And Methods: In this randomized, double-blind study, participants self-administered individualized bolus doses of BCLIS or LIS during two 14-day periods in a crossover fashion. Postprandial blood glucose (BG) was assessed after individualized solid mixed meal tests (MMTs) (50% carbohydrate, 29% fat, 21% protein), with additional randomization for the sequence of timing of insulin administration, immediately (t0), 15 minutes before (t - 15) and 15 minutes after (t + 15) meal start on days 1, 2 and 3, and with t0 administration on day 14.