A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5)

Autor: Tadej Battelino, J. Hans DeVries, Theis Gondolf, Mark L. Evans, David C. Klonoff, A. Hyseni, Eric Renard, Wendy Lane, Tina Graungaard, Hans-Peter Kempe
Přispěvatelé: Mills Peninsula Medical Center, MRC Epidemiology Unit [Cambridge, UK] (Wellcome Trust-MRC Institute of Metabolic Science), University of Cambridge [UK] (CAM)-Addenbrooke’s Hospital [Cambridge, UK]-Wellcome Trust-MRC Institute of Metabolic Science (IMS), Mountain Diabetes and Endocrine Center, Centre for Diabetes and Nutrition Ludwigshafen, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Université de Montpellier (UM), Amsterdam UMC - Amsterdam University Medical Center, Profil Institute for Metabolic Research GmbH, Novo Nordisk Foundation Center for Basic Metabolic Research (CBMR), Faculty of Health and Medical Sciences, University of Copenhagen = Københavns Universitet (UCPH)-University of Copenhagen = Københavns Universitet (UCPH), Novo nordisk pharma, University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Nowak, Cécile, Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Klonoff, David C [0000-0002-0624-698X], Renard, Eric [0000-0002-3407-7263], DeVries, J Hans [0000-0001-9196-9906], Battelino, Tadej [0000-0002-0273-4732], Apollo - University of Cambridge Repository, Endocrinology, AGEM - Endocrinology, metabolism and nutrition
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Adult
Male
medicine.medical_specialty
endocrine system diseases
Endocrinology
Diabetes and Metabolism
[SDV]Life Sciences [q-bio]
030209 endocrinology & metabolism
030204 cardiovascular system & hematology
Rate ratio
Infusions
Subcutaneous
Gastroenterology
Insulin aspart
Excipients
03 medical and health sciences
0302 clinical medicine
Endocrinology
Insulin Infusion Systems
Double-Blind Method
Internal medicine
Statistical significance
Internal Medicine
medicine
Clinical endpoint
Humans
Hypoglycemic Agents
Insulin Aspart
Dosage Forms
Glycated Hemoglobin
[SDV.MHEP.EM] Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
Type 1 diabetes
business.industry
CSII
Original Articles
Middle Aged
[SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
medicine.disease
Confidence interval
Hypoglycemia
3. Good health
Discontinuation
Clinical trial
Postprandial
Diabetes Mellitus
Type 1
Insulin therapy
Original Article
Female
business
medicine.drug
Zdroj: Diabetes, Obesity and Metabolism
Diabetes, Obesity and Metabolism, 2018, pp.961-967. ⟨10.1111/dom.13610⟩
Diabetes, Obesity and Metabolism, Wiley, 2018, ⟨10.1111/dom.13610⟩
Diabetes, Obesity & Metabolism
Diabetes, obesity & metabolism, 21(4), 961-967. Wiley-Blackwell
ISSN: 1462-8902
1463-1326
DOI: 10.1111/dom.13610⟩
Popis: International audience; Aim: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D).Materials and methods: This was a double-blind, treat-to-target, randomized, 16-week trial investigating CSII treatment with faster aspart (n = 236) or IAsp (n = 236). All available information, regardless of treatment discontinuation, was used for the evaluation of effect.Results: Faster aspart was non-inferior to IAsp regarding the change from baseline in glycated haemoglobin (HbA1c; primary endpoint). The mean HbA1c changed from 58.4 mmol/mol (7.5%) at baseline to 57.8 mmol/mol (7.4%) with faster aspart and to 56.8 mmol/mol (7.4%) with IAsp after 16 weeks' treatment, with an estimated treatment difference (ETD) of 1.0 mmol/mol (95% confidence interval [CI] 0.14; 1.87) or 0.09% (95% CI 0.01; 0.17; P < 0.001) for non-inferiority (0.4% margin; P < 0.02 for statistical significance in favour of IAsp). Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/dL [95% CI -25.7; -7.0]; P = 0.001), with statistically significant reductions also at 30 minutes and 2 hours. The improvement in PPG was reflected in the change from baseline in 1-hour interstitial glucose increment after all meals (ETD -0.21 mmol/L [95% CI -0.31; -0.11] or -3.77 mg/dL [95% CI -5.53; -2.01]). There was no statistically significant difference in the overall rate of severe or blood glucose-confirmed hypoglycaemia (estimated rate ratio 1.00 [95% CI 0.85; 1.16]). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and 4-week run-in periods (4 vs 0).Conclusions: Faster aspart provides an effective and safe option for CSII treatment in T1D.
Databáze: OpenAIRE
Externí odkaz: