ADO09, a co-formulation of the amylin analogue pramlintide and the insulin analogue A21G, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes
| Autor: | Grégory Meiffren, Grit Andersen, J. Hans DeVries, Olivier Soula, Susanne Famulla, Richard Charvet, Martin Gaudier, Tim Heise, Aymeric Ranson, Rosy Eloy, You-Ping Chan, Cyril Seroussi |
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| Přispěvatelé: | Endocrinology, APH - Health Behaviors & Chronic Diseases, Amsterdam Gastroenterology Endocrinology Metabolism |
| Rok vydání: | 2020 |
| Předmět: |
Blood Glucose
medicine.medical_specialty type 1 diabetes Endocrinology Diabetes and Metabolism medicine.medical_treatment Insulin analog 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Glucagon 03 medical and health sciences 0302 clinical medicine Endocrinology Internal medicine pharmacodynamics Internal Medicine medicine Insulin lispro Humans Hypoglycemic Agents Insulin antidiabetic drug Type 1 diabetes Cross-Over Studies Insulin Lispro business.industry digestive oral and skin physiology clinical trial medicine.disease Postprandial Period Pramlintide Islet Amyloid Polypeptide Postprandial Diabetes Mellitus Type 1 glucagon insulin therapy Pharmacodynamics business medicine.drug |
| Zdroj: | Diabetes, obesity & metabolism, 23(4), 961-970. Wiley-Blackwell |
| ISSN: | 1463-1326 1462-8902 |
| Popis: | 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. The insulin dose was 7.5 U and the pramlintide dose was 45 μg. Blood glucose, glucagon and acetaminophen concentrations were assessed as pharmacodynamic endpoints; insulin and pramlintide concentrations were analysed as pharmacokinetic endpoints, and safety and tolerability were assessed. Results: Compared with Lispro, ADO09 reduced postprandial blood glucose (ppBG) excursions by more than 95% in the first hour postmeal (mean ± SD ∆AUC BG 0-1 h: 1.4 ± 9.9 mg*h/dL vs. 43.5 ± 15.3 mg*h/dL; p |
| Databáze: | OpenAIRE |
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