Intensification of Basal Insulin Therapy with Step-Wise Addition of Insulin Aspart Boluses vs. Basal-Bolus Therapy: The FullSTEP™ Study

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

doi:10.1016/j.jcjd.2013.08.125

Cited by 3 publications

(4 citation statements)

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“…In support of the current study, results from the Self-Titration With Apidra to Reach Target (START) and FullSTEP trials demonstrated similar decreases in HbA 1c when a basal-bolus regimen was initiated in patients inadequately controlled on basal insulin plus OADs (26,27). The START Study showed that similar glycemic control can be achieved by patients using a breakfast preprandial insulin titration approach compared with a physician-managed strategy (26).…”

Section: Discussionsupporting

confidence: 65%

“…The START Study showed that similar glycemic control can be achieved by patients using a breakfast preprandial insulin titration approach compared with a physician-managed strategy (26). The FullSTEP study demonstrated that a stepwise insulin approach resulted in greater patient treatment satisfaction with fewer hypoglycemic events than a full basal-bolus regimen (27). However, the study initiated the first prandial insulin dose at the largest meal, the prandial dose was adjusted by the study investigators, and both AUTONOMY and START began the prandial therapy at the first meal of the day.…”

Section: Discussionmentioning

confidence: 99%

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AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes

et al. 2014

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OBJECTIVETo compare two self-titration algorithms for initiating and escalating prandial insulin lispro in patients with type 2 diabetes inadequately controlled on basal insulin. RESEARCH DESIGN AND METHODSThe trial was designed as two independent, multinational, parallel, open-label studies (A and B), identical in design, to provide substantial evidence of efficacy and safety in endocrine and generalist settings. Subjects were 18-85 years old (study A: N = 528; study B: N = 578), on basal insulin plus oral antidiabetic drugs for ‡3 months, and had an HbA 1c 7.0% to £12.0% (>53.0 to £107.7 mmol/mol). Once optimized on insulin glargine, subjects were randomized to one of two self-titration algorithm groups adjusting lispro either every day (Q1D) or every 3 days (Q3D) for 24 weeks. The primary outcome was the change in HbA 1c from baseline. The primary and secondary objectives were evaluated for the overall population and subjects ‡65 years old. . The incidence and rate of hypoglycemia were similar for Q3D and Q1D in both studies. In general, no clinically relevant differences were found between the two algorithms in subjects ‡65 years old in either study. RESULTS Baseline CONCLUSIONSPrandial insulin lispro can effectively and safely be initiated, by either of two selftitrated algorithms, in a variety of practice settings.

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Section: Discussionsupporting

confidence: 65%

Section: Discussionmentioning

confidence: 99%

AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes

et al. 2014

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“…Stepwise addition of prandial insulin is recommended in patients inadequately controlled on basal insulin plus OADs. The results of the Full STEP Study showed that stepwise prandial insulin intensification provided glycemic control non-inferior to a full basal-bolus regimen after 32 weeks with significantly lower hypoglycemia risk and improved patient satisfaction [33].…”

Section: Insulin Therapy In Dkd G1-2mentioning

confidence: 99%

Insulin therapy in diabetic kidney disease

Liu

Zhao

Xiong

et al. 2021

Diabetic Nephropathy

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Diabetic kidney disease (DKD) is the main cause of end-stage renal disease (ESRD). The use of insulin represents a challenge in patients with DKD due to the patient and medication issues. Insulin regimens, insulin dosing, and titration need to be individualized based on the patient's age, renal function, and comorbidities to improve glycemic control and reduce the risk of hypoglycemia. Insulin is the primary treatment in all patients with type 1 diabetes mellitus (T1DM) and DKD. For patients with type 2 diabetes mellitus (T2DM) and early stage of DKD, basal insulin combined with oral antidiabetic drugs (OADs) is recommended. In patients with middle and advanced DKD, it is necessary to adjust the dose of insulin according to stages of DKD, and the use of insulin analogs is recommended. In particular, elderly patients with DKD can simplify their insulin regimen to reduce the risk of hypoglycemia. In pregnant women with DKD, insulin requirements also vary based on parity and the stage of pregnancy.

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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).…”

mentioning

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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Intensification of Basal Insulin Therapy with Step-Wise Addition of Insulin Aspart Boluses vs. Basal-Bolus Therapy: The FullSTEP™ Study

Cited by 3 publications

References 0 publications

AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes

AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes

Insulin therapy in diabetic kidney disease

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

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