Modified release terbutaline (SKP1052) for hypoglycaemia prevention: a proof-of-concept study in people with type 1 diabetes mellitus
| Autor: | G. Vergnault, David R. Owens, K. Kaiser, Tim Heise, A. Fischer, P. Ibarra, Karim Bagate, J.-M. Cardot, L. Nosek |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Adolescent Injections Subcutaneous Endocrinology Diabetes and Metabolism Terbutaline Insulin Glargine Placebo Drug Administration Schedule Endocrinology Pharmacokinetics Internal medicine Internal Medicine medicine Clinical endpoint Humans Hypoglycemic Agents Insulin Fasting hyperglycaemia Single-Blind Method Morning Type 1 diabetes Cross-Over Studies Insulin glargine business.industry Fasting Middle Aged medicine.disease Hypoglycemia Insulin Long-Acting Diabetes Mellitus Type 1 Delayed-Action Preparations Hyperglycemia Anesthesia Female business medicine.drug |
| Zdroj: | Diabetes, Obesity and Metabolism. 14:1137-1144 |
| ISSN: | 1462-8902 |
| DOI: | 10.1111/dom.12003 |
| Popis: | Aims: In this randomized, single blind, cross-over study 2.5mg and 5mg of the modified-release terbutaline formulation (SKP-1052) were compared with conventional immediate-release terbutaline (IRT, 5mg) and placebo on overnight blood glucose (BG) and hypoglycaemia in 30 subjects with type 1 diabetes mellitus. Methods: Subjects received subcutaneous injections of insulin glargine (individualized doses) before dinner. SKP-1052, IRT or placebo was administered around 21:00 hours. BG and terbutaline concentrations were monitored overnight for 10 h post-dosing. Endpoints comprised of the nadir BG (BGn 0–10 h, primary endpoint), mean overnight BG (BGmean), morning BG (BGmorning) and hypoglycaemia rates as well as pharmacokinetic (PK) endpoints. Results: SKP-1052 delayed release of terbutaline by 2 h [PK-tmax (mean±SD) 5.0±2.1 h (2.5 mg) and 4.7±1.7 h (5 mg) vs. 2.6±1.3 h with IRT, p |
| Databáze: | OpenAIRE |
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