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

Summary 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 saf...

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Bibliographic Details
Published in:The Lancet (British edition) 2012-04, Vol.379 (9825), p.1489-1497
Main Authors: Heller, Simon, Prof, Buse, John, Prof, Fisher, Miles, Prof, Garg, Satish, Prof, Marre, Michel, Prof, Merker, Ludwig, MD, Renard, Eric, Prof, Russell-Jones, David, Prof, Philotheou, Areti, MBChB, Francisco, Ann Marie Ocampo, MD, Pei, Huiling, PhD, Bode, Bruce, MD
Format: Article
Language:English
Subjects:
Adult
adults
Biological and medical sciences
blood glucose
Clinical medicine
Committees
complications
Diabetes
diabetes mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Diabetes. Impaired glucose tolerance
Drug Administration Schedule
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Etiopathogenesis. Screening. Investigations. Target tissue resistance
Female
General aspects
Glycated Hemoglobin A - analysis
glycemic control
hemoglobin
Hemoglobin A, Glycosylated
Hospitals
Humans
hypoglycemia
Hypoglycemic Agents
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Insulin
Insulin Aspart
Insulin Aspart - administration & dosage
Insulin Glargine
Insulin, Long-Acting
Insulin, Long-Acting - administration & dosage
Insulin, Long-Acting - adverse effects
Insulin, Long-Acting - therapeutic use
insulin-dependent diabetes mellitus
Internal Medicine
Life Sciences
Male
Medical sciences
patients
Pharmaceutical industry
Product development
Public speaking
risk
Risk reduction
Side effects
Stratification
therapeutics
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Summary:Summary 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 [HbA1c ] ≤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 HbA1c 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, HbA1c 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
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(12)60204-9