Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial

Rodbard, Helena W.; Visco, Virginia E.; Andersen, H.; Hiort, Line Conradsen; Shu, David H.W.

doi:10.1016/s2213-8587(13)70090-1

Cited by 82 publications

(110 citation statements)

References 16 publications

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“…In this regard, the AUTONOMY study is to be welcomed alongside the recent FullSTEP study (5). Both trials examined patient-driven titration of prandial insulin in type 2 diabetes previously inadequately controlled with basal insulin.…”

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confidence: 99%

“…The FullSTEP study compared stepwise addition of bolus insulin with a full basal-bolus regimen; AUTONOMY compared a daily and a 3-day protocol for prandial insulin titration. Unfortunately, the AUTONOMY study report appears to misrepresent aspects of the FullSTEP study (5).…”

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confidence: 99%

“…These two statements are incorrect; FullSTEP examined patient-driven treatment intensification in two arms: three daily prandial doses added to basal insulin from the start of the treatment period and use of one, two, or three prandial boluses added in a stepwise manner. In both arms, patients selftitrated their prandial insulin dose (5). By contrast, in the AUTONOMY study, Edelman et al added one to three boluses sequentially in both arms (1).…”

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confidence: 99%

“…In the stepwise arm of the FullSTEP study, additional boluses were added at predetermined intervals if the target HbA 1c of ,7.0% (53 mmol/mol) was not achieved (5). In AUTONOMY, investigators added additional boluses at unspecified time stages "if necessary" (1).…”

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confidence: 99%

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Comment on Edelman et al. AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes. Diabetes Care 2014;37:2132–2140

Rodbard¹,

Karolicki

2014

Diabetes Care

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confidence: 99%

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Comment on Edelman et al. AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes. Diabetes Care 2014;37:2132–2140

Rodbard¹,

Karolicki

2014

Diabetes Care

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“…We appreciate that the authors of FullSTEP have taken this opportunity to reinforce how a patient-centric approach to insulin therapy intensification can achieve improvements in blood glucose control. However, before the description in the commentary, the management of prandial insulin titration in the FullSTEP study (3,4) was not a primary emphasis, and we welcome the clarification that, indeed, FullSTEP used the same patient self-titration algorithms for adding mealtime insulin in both treatment arms (3). This patient self-titration algorithm was only very briefly mentioned and not described in the original article (3).…”

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confidence: 99%

Response to Comment on Edelman et al. AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes. Diabetes Care 2014;37:2132–2140

et al. 2014

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Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

et al. 2018

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LeaderT here is a demand from regulators that new treatments for the management of hyperglycaemia in people with type 2 diabetes should not increase cardio vascular risk. 1,2 For most new therapies this will include the performance of a dedicated randomised-controlled cardiovascular outcomes trial (CVOT). This can be conducted prior to licensing, like the SUSTAIN-6 trial with semaglutide, 3 or post-licensing, like the LEADER trial with liraglutide. 4 The results of CVOTs with albiglutide, a once-weekly GLP-1 receptor agonist, and linagliptin, a DPP-4 inhibitor, were presented at the recent meeting of the European Association for the Study of Diabetes (EASD) in Berlin. 5,6 As there are now several completed trials with GLP-1 receptor agonists and DPP-4 inhibitors it is relevant to place the results of these studies in the context of the results of previous studies. Harmony OutcomesAlbiglutide is a once-weekly GLP-1 receptor agonist composed of two copies of modified human GLP-1 fused to human albumin. It was available for clinical use in the US and Europe from 2014. In the summer of 2017 the manufacturer GlaxoSmithKline announced that albiglutide would be withdrawn from the worldwide market by 2018 for economic reasons that were not detailed, and marketing ceased in July 2018. A lack of potency compared to other GLP-1 receptor agonists, 7 and the inconvenience to the patient of having to reconstitute the lyophilised powder with a diluent and wait 15-30 minutes before injection 8 may have contributed to the low use of albiglutide in countries where other onceweekly GLP-1 receptor agonists were available.Harmony Outcomes was a post-licensing CVOT comparing albiglutide and placebo in 9463 people with type 2 diabetes and established cardiovascular disease, including coronary vascular disease, cerebrovascular disease and peripheral arterial disease. 5 Other inclusion criteria included age over 40 years, and HbA1c over 7.0% (53mmol/mol). At baseline 70% of participants had coronary heart disease, 47% had a previous myocardial infarction and 20% were recorded as having baseline heart failure by their local clinical investigator. Subjects were followed for a median of 1.6 years and the primary outcome was major adverse cardiovascular events (MACE), a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.Subjects in the albiglutide arm had a statistically significant 22% reduction in MACE compared to the placebo group. This was despite one-quarter of the subjects discontinuing therapy during this short study. Of the components of the MACE outcome, myocardial infarction (fatal or non-fatal) was significantly reduced, with insignificant effects on stroke and cardiovascular death. The number of subjects needed to treat with albiglutide for 1.6 years to prevent one major adverse cardiovascular event was 50. In the placebo group there was as expected a greater use of sulphonylureas and insulin, including greater use of bolus insulin. Hypoglycaemia rates were lower with albiglutide, including le...

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Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial

Cited by 82 publications

References 16 publications

Comment on Edelman et al. AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes. Diabetes Care 2014;37:2132–2140

Comment on Edelman et al. AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes. Diabetes Care 2014;37:2132–2140

Response to Comment on Edelman et al. AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes. Diabetes Care 2014;37:2132–2140

Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

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