Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial.

Abstract : BACKGROUND: Intensive basal-bolus insulin therapy has been shown to improve glycaemic control and reduce the risk of long-term complications that are associated with type 1 diabetes mellitus. Insulin degludec is a new, ultra-longacting basal insulin. We therefore compared the efficacy and safety of insulin degludec and insulin glargine, both administered once daily with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes. METHODS: In an open-label, treat-to-target, non-inferiority trial, undertaken at 79 sites (hospitals and centres) in six countries, adults (aged ≥18 years) with type 1 diabetes (glycated haemoglobin [HbA(1c)] ≤10% [86 mmol/mol]), who had been treated with basal-bolus insulin for at least 1 year, were randomly assigned in a 3:1 ratio, with a computer-generated blocked allocation sequence, to insulin degludec or insulin glargine without stratification by use of a central interactive response system. The primary outcome was non-inferiority of degludec to glargine, assessed as a reduction in HbA(1c) after 52 weeks, with the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00982228. FINDINGS: Of 629 participants, 472 were randomly assigned to insulin degludec and 157 to insulin glargine; all were analysed in their respective treatment groups. At 1 year, HbA(1c) had fallen by 0*40% points (SE 0*03) and 0*39% points (0*07), respectively, with insulin degludec and insulin glargine (estimated treatment difference -0*01% points [95% CI -0*14 to 0*11]; p<0*0001 for non-inferiority testing) and 188 (40%) and 67 (43%) participants achieved a target HbA(1c) of less than 7% (<53 mmol/mol). Rates of overall confirmed hypoglycaemia (plasma glucose <3*1 mmol/L or severe) were similar in the insulin degludec and insulin glargine groups (42*54 vs 40*18 episodes per patient-year of exposure; estimated rate ratio [degludec to glargine] 1*07 [0*89 to 1*28]; p=0*48). The rate of nocturnal confirmed hypoglycaemia was 25% lower with degludec than with glargine (4*41 vs 5*86 episodes per patient-year of exposure; 0*75 [0*59 to 0*96]; p=0*021). Overall serious adverse event rates (14 vs 16 events per 100 patient-years of exposure) were similar for the insulin degludec and insulin glargine groups. INTERPRETATION: Insulin degludec might be a useful basal insulin for patients with type 1 diabetes because it provides effective glycaemic control while lowering the risk of nocturnal hypoglycaemia, which is a major limitation of insulin therapy. FUNDING: Novo Nordisk.
Type de document :
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Lancet, Elsevier, 2012, 379 (9825), pp.1489-97. 〈10.1016/S0140-6736(12)60204-9〉
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http://hal.univ-brest.fr/hal-00932056
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Soumis le : jeudi 16 janvier 2014 - 11:23:00
Dernière modification le : mercredi 10 janvier 2018 - 14:42:02

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Simon Heller, John Buse, Miles Fisher, Satish Garg, Michel Marre, et al.. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial.. Lancet, Elsevier, 2012, 379 (9825), pp.1489-97. 〈10.1016/S0140-6736(12)60204-9〉. 〈hal-00932056〉

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