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

Heller, Simon; Buse, John B.; Fisher, Miles; Garg, Satish K.; Marre, Michel; Merker, Ludwig; Renard, Éric; Russell‐Jones, David; Philotheou, Areti; Francisco, Ann Marie Ocampo; Pei, Huiling; Bode, Bruce W.

doi:10.1016/s0140-6736(12)60204-9

Cited by 328 publications

(382 citation statements)

References 18 publications

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“…In a previous phase III clinical study comparing insulin degludec with insulin glargine in a basal–bolus regimen, the degludec group showed a reduced frequency of hypoglycemia, particularly at night, while showing non‐inferiority to glargine in its blood glucose‐lowering effect13, 17. In a subsequent long‐term observational study, the basal and total insulin doses were lower in the degludec group compared with the glargine group18.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24‐week results from the observational study in routine clinical practice

Kobuke

Yoneda

Nakanishi

et al. 2015

J of Diabetes Invest

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Aims/IntroductionInsulin degludec, a new long‐acting insulin analog, showed its better glycemic control and reduced risk of hypoglycemia. This is the first prospective observational study that evaluated the efficacy and safety of insulin degludec in routine clinical practice.Materials and MethodsJapanese patients with type 1 or type 2 diabetes mellitus receiving basal–bolus insulin therapy were switched their basal insulin to degludec, and prospectively observed over a 24‐week course. The Diabetes Therapy‐Related Quality of Life questionnaire was administered before and 12 weeks after switching.ResultsThe participants were 80 diabetes patients = (type 1, 44; type 2, 36). In the type 1 group, there was no difference in glycated hemoglobin levels between the pre‐switching and 24‐week measurements (from 62 to 62 mmol/mol, P = 0.768), whereas the daily insulin dose (per kg of bodyweight) decreased significantly (basal, from 0.25 to 0.20 U/kg, P < 0.001; bolus, from 0.40 to 0.37 U/kg, P = 0.001). In the type 2 group, glycated hemoglobin levels decreased after switching (from 60 to 58 mmol/mol, P = 0.028). In the type 1 group, the frequency of hypoglycemia decreased significantly after switching, but not significantly in the type 2 group. Patient satisfaction with the control of hypoglycemia tended to improve in the type 1 group.ConclusionsCompared with existing long‐acting insulin, degludec can maintain glycemic control at a lower insulin dose and frequency of hypoglycemia in type 1 diabetes, while it can improve glycemic control at an equal insulin dose in type 2 diabetes.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24‐week results from the observational study in routine clinical practice

Kobuke

Yoneda

Nakanishi

et al. 2015

J of Diabetes Invest

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“…65 Pivotal trials by this new type of insulin showed that in type 1 diabetes, degludec insulin, compared with glargine in a basal-bolus regimen with a rapid acting analogues, with the same glycemic control, resulted in less nocturnal hypoglycemia. 66 In type 2 diabetes, when compared to the glargine in a basal dose regimen only on equal glycemic control, it showed a significant reduction of all 24 h-daily, not only nocturnal, hypoglycemic episodes. 67 These data were well confirmed in elderly subjects too, those aged over 65 years, 68 normally more vulnerable to hypoglycemic episodes.…”

Section: Preventing Hypoglycemiamentioning

confidence: 94%

The clinical impact of hypoglycemia in hospitalized patients

Borzı̀

Fontanella

2015

Ital J Med

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Hypoglycemia is a very common problem, mostly in frail, severely ill, older hospitalized patients. Hypoglycemia has been implicated in the development of adverse clinical outcomes, including an increased mortality. Fear of iatrogenic hypoglycemia remains an obstacle to adequate inpatient glycemic control. It may be considered as a marker of disease, rather than cause in itself of undesirable events. Several factors, such as treatment with exogenous insulin, mismatch between insulin administration and meal intake with the loss of normal counter regulatory responses, place patients with diabetes at higher risk for hypoglycemia than the ones without diabetes. In this review we discuss the causes and predictors of hypoglycemia in non-critically ill hospitalized patients and how to prevent them. Subcutaneous insulin with basal-bolus regimen rather than sliding scale and the use of analogues may minimize hypoglycemic events. In-patient glycemic management should be patient-centered, following the current guidelines, and aimed to prevent hypoglycemic events.Correspondence: Andrea Fontanella, Dipartimento di Medicina, Ospedale del Buon Consiglio Fatebenefratelli, via Manzoni 220, 80123 Napoli, Italy. E-mail: andreafontanella52@gmail.com Key words: hypoglycemia, diabetes, non-critical illness, inpatients.Received for publication: 6 October 2014. Accepted for publication: 3 December 2014.This work is licensed under a Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).

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“…These form a soluble depot in the subcutaneous tissue from which IDeg monomers slowly dissociate. Studies to determine the PK/PD profile of IDeg demonstrate an evenly distributed glucose-lowering profile, with a terminal half-life of more than 25 hours under steady state conditions [27] and a duration of action reported to be over 40 hours [28].…”

Section: Pharmacokinetic/pharmacodynamic Profiles Of Novel Basal Analmentioning

confidence: 99%

“…In the BEGIN Basal-Bolus Type 1 study, a 52-week, parallel-group, phase 3 study, T1DM patients previously treated with basal-bolus insulin for ≥1 year received either IDeg or Gla-100 QD with mealtime insulin aspart [28]. Both basal and mealtime insulin were titrated to achieve blood glucose ~70-90 mg/dl (3.9-5.0 mmol/l).…”

Section: Insulin Degludecmentioning

confidence: 99%

Hypoglycemia with New Generation Basal Analog Insulins: A Descriptive Critical Review

Thrasher¹

2015

J Diabetes Metab

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Optimizing the treatment of people with diabetes relies on balancing the benefits of glycemic control with the risk of hypoglycemia. Although insulin is essential for treating patients with type 1 diabetes mellitus, patient and physician concerns regarding an increased risk of hypoglycemia can lead to delays in initiating insulin treatment in patients with type 2 diabetes mellitus. This clinical inertia contributes to reduced glycemic control and poorer outcomes for patients. Advances in insulin agents have reduced the risk of hypoglycemia. In particular, the introduction of insulin glargine, the first basal analog insulin with a 24-hour glucose-lowering profile with no pronounced peak, represented a significant step towards achieving this goal.To further improve patient management, a number of insulin formulations and molecules are in development and are designed to have pharmacokinetic/pharmacodynamic (PK/PD) profiles allowing closer mimicking of normal physiologic insulin release. Here we review these new agents, and discuss their hypoglycemic risk as reported in clinical trials. In addition, the difficulties in making comparative evaluations from studies with different patient populations and definitions of hypoglycemia are discussed. Solutions to improve future clinical trials are suggested. In general, the improved PK/PD profiles of new-generation insulins appear to result in better clinical outcomes in terms of hypoglycemia. What is needed are head-to-head trials using standardized methods and criteria to allow clinicians to compare hypoglycemia rates between insulins, and help them to discuss appropriate choices of therapy with their patients.

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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

Cited by 328 publications

References 18 publications

Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24‐week results from the observational study in routine clinical practice

Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24‐week results from the observational study in routine clinical practice

The clinical impact of hypoglycemia in hospitalized patients

Hypoglycemia with New Generation Basal Analog Insulins: A Descriptive Critical Review

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