Ultra-rapid BioChaperone Lispro improves postprandial blood glucose excursions vs insulin lispro in a 14-day crossover treatment study in people with type 1 diabetes
| Autor: | Aymeric Ranson, Martin Gaudier, Cyril Seroussi, Tim Heise, Bertrand Alluis, J. Hans DeVries, Grit Andersen, Grégory Meiffren, Olivier Soula, Daniela Lamers |
|---|---|
| Přispěvatelé: | Endocrinology, AGEM - Endocrinology, metabolism and nutrition |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Blood Glucose Male Adolescent Endocrinology Diabetes and Metabolism medicine.medical_treatment 030209 endocrinology & metabolism 030204 cardiovascular system & hematology 03 medical and health sciences Young Adult 0302 clinical medicine Endocrinology Bolus (medicine) Pharmacokinetics Double-Blind Method Internal Medicine medicine Insulin lispro Humans Hypoglycemic Agents Meals Meal Type 1 diabetes Cross-Over Studies Insulin Lispro business.industry Insulin Middle Aged medicine.disease Postprandial Period Postprandial Diabetes Mellitus Type 1 Tolerability Anesthesia Female business medicine.drug |
| Zdroj: | Diabetes, obesity & metabolism, 20(11), 2627-2632. Wiley-Blackwell |
| ISSN: | 1462-8902 |
| Popis: | Aim 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. Pharmacokinetic (PK) variables were assessed for t0 MMTs. Participants also used individualized BCLIS or LIS doses immediately before meals during two 10-day outpatient periods with an unchanged basal insulin regimen. Results Overall, 35 participants completed both treatment periods. In MMTs with t0 administration, the higher early postprandial PK exposure of BCLIS led to significant reductions in 1- to 2-hour postprandial BG excursions by 30% to 40% vs LIS and the accelerated absorption and action of BCLIS persisted over 14 days. There was no difference in glucose excursion over the full 360-minute postprandial period. Postprandial BG control was similar between BCLIS injected at t + 15 and LIS injected at t0. BCLIS was shown to have safety and tolerability similar to LIS. No injection site reactions occurred with BCLIS. Conclusions BCLIS was well tolerated and safe over 14 days of treatment and significantly improved postprandial BG vs LIS when administered at mealtime. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text