The importance of the initial period of basal insulin titration in people with diabetes

Khunti, Kamlesh; Giorgino, Francesco; Berard, Lori; Mauricio, Dı́dac; Harris, Stewart B.

doi:10.1111/dom.13946

Cited by 26 publications

(38 citation statements)

References 62 publications

(107 reference statements)

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“…Le linee guida internazionali raccomandano l'impiego dell'insulina basale in pazienti affetti da DM2 che non raggiungono gli obiettivi di trattamento nonostante duplice/triplice terapia orale e/o con gli agonisti del recettore del GLP-1 o in presenza di grave scompenso glicometabolico con sintomi/segni di deficit insulinico ( Fig. 1) [1]. In Italia, circa il 30% dei pazienti affetti da DM2 fa uso di insulina, da sola o in associazione ad altri ipoglicemizzanti (Annali AMD 2018).…”

Section: Diabete Mellito DI Tipounclassified

“…Le insuline di seconda generazione sono caratterizzate da una durata d'azione più lunga, da un profilo farmacocinetico con picco meno evidente e da minore variabilità di azione da un giorno all'altro. Trial randomizzati controllati e studi di Real World Evidence (RWE) hanno dimostrato che, a parità di efficacia, l'impiego di insuline basali di seconda generazione consente di ridurre il rischio di ipoglicemia, che costituisce uno dei principali ostacoli all'intensificazione terapeutica [1].…”

Section: Diabete Mellito DI Tipounclassified

“…La dose iniziale consigliata di insulina basale è di 10 UI/die (o 0,1-0,2 UI/kg/die), ma la prima prescrizione deve necessariamente essere seguita da una fase di titolazione, della durata di 8-12 settimane, durante la quale ci si prefigge di raggiungere il target personalizzato di glicemia a digiuno (FPG), solitamente compreso fra 80 e 130 mg/dl, evitando ipoglicemie [1]. La titolazione può essere gestita dal diabetologo oppure dal paziente stesso, secondo algoritmi di autotitolazione.…”

Section: Diabete Mellito DI Tipounclassified

“…Un buon controllo glicemico è essenziale per ridurre l'incidenza e la progressione delle complicanze micro-e macrovascolari nelle persone con diabete mellito di tipo 1 (DM1) e di tipo 2 (DM2). Tuttavia, gran parte dei pazienti mantiene un controllo insoddisfacente per lunghi periodi di tempo [1]. L'introduzione di un'insulina basale è una valida opzione per l'intensificazione del trattamento nelle persone con DM2.…”

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Gestione iniziale della terapia con insulina basale nel paziente diabetico

2020

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Section: Diabete Mellito DI Tipounclassified

Section: Introduzioneunclassified

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Gestione iniziale della terapia con insulina basale nel paziente diabetico

2020

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“…The review by Khunti et al nicely summarizes the issues and challenges of starting basal insulin (BI) therapy in patients with type 2 diabetes. The authors correctly point out that therapeutic inertia is a major barrier, and for insulin treatment, divide it into three phases, initiation inertia, titration inertia (the first 8‐12 weeks) and maintenance inertia.…”

Section: Percentage Increase In Wholesale Costs Of Second‐generation mentioning

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Second‐generation basal insulins to initiate insulin therapy in type 2 diabetes: A need for clinical evidence before incurring increased costs

Davidson

2020

Diabetes Obesity Metabolism

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1 nicely summarizes the issues and challenges of starting basal insulin (BI) therapy in patients with type 2 diabetes. The authors correctly point out that therapeutic inertia is a major barrier, and for insulin treatment, divide it into three phases, initiation inertia, titration inertia (the first 8-12 weeks) and maintenance inertia. They state that the benefits of tight control are most evident if control is achieved soon after starting antihyperglycaemia therapy, especially during the first year, but point out that poor glycaemic control for long periods of time characterizes many patients with type 2 diabetes.Regarding initiation therapeutic inertia, the reluctance to start insulin leads to long delays (of up to 7 years) after patients fail combinations of non-insulin drugs, and even at that point, many patients do not receive insulin. [2][3][4][5][6] When insulin was started in patients with type 2 diabetes, HbA1c levels ranged from 8.9% to 9.8%, 2,3,6-9 averaging 9.3%. Because most patients starting insulin have had diabetes for 8-10 years, poorly controlled for much of that time, it is not clear that rapid achievement of control when a BI is started will have the same beneficial effect on the complications as it might have achieved if started shortly after diagnosis.The authors also point out that fear of hypoglycaemia (by both patients and providers) is a major factor in initiation therapeutic inertia. Furthermore, after starting insulin, people who experience hypoglycaemia during the first 6 months of treatment are more probable to discontinue BIs. 10 Based on the differences in the pharmacokinetics of first-generation (glargine U-100 and detemir) and second-generation (glargine U-300 and degludec) BIs, they recommend using the second-generation BIs to reduce the risk of hypoglycaemia, postulating that this "may potentially help to improve treatment adherence" compared with using first-generation BIs.Costs are a major concern for people requiring insulin. 11 Because the cost of insulins in the United States has tripled between 2001 and 2012 12 and doubled between 2012 and 2016, 13 25% of insulinrequiring patients are currently rationing their insulin doses 14 in the United States. Second-generation BIs are more expensive than firstgeneration glargine U-100 or bedtime neutral protamine Hagedorn (NPH) vials, although not detemir or NPH pens (Table 1). The costs of insulin in other countries (where governments can negotiate with the companies producing insulin) are much less than in the United States, but the second-generation BIs are still more expensive than the firstgeneration BIs. Therefore, it behoves us to closely examine the clinical evidence for the recommendation of using second-generation BIs when initiating insulin therapy.The authors have provided randomized controlled trials (RCTs) and real-world experience (RWE) studies to support their recommendation.Regarding RCTs, the BRIGHT study 15 compared the two secondgeneration BIs and therefore the results are not germane to their recommendation. Th...

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Comparative Effectiveness of Switching From First-Generation Basal Insulin to Glargine 300 U/ml or Degludec 100 U/ml in Type 1 Diabetes: The RESTORE-1 Study

et al. 2020

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Introduction Following pivotal trials, real-world evidence is important to assess the impact of new drugs in everyday clinical practice. The RESTORE-1 study aimed to compare effectiveness and safety of the second-generation basal insulins (2BI), i.e., insulin glargine 300 U/ml (Gla-300) vs. degludec 100 U/ml (IDeg-100), in type 1 diabetes (T1D). Methods Retrospective, non-inferiority, multicenter study, based on electronic medical records. All patients switching to Gla-300 or IDeg-100 from first-generation basal insulins (1BI) were 1:1 propensity score matched (PSM). Changes during 6 months in HbA1c (primary endpoint), fasting plasma glucose (FPG), body weight, and insulin doses were assessed using linear mixed models for repeated measures. Incidence rates (IR) of hypoglycemic events were assessed. Results Overall, 19 centers provided data on 585 patients in each PSM cohort. For both groups, statistically significant reductions in HbA1c from baseline to 6 months were documented: − 0.20%; (95% CI − 0.32; − 0.08) in the Gla-300 group and − 0.14%; (95% CI − 0.24; − 0.04) in the IDeg-100 group. The non-inferiority of Gla-300 vs. IDeg-100 was confirmed (non-inferiority margin of 0.30%; upper 95% CI at 6 months, 0.09%). No statistically significant between-group differences emerged in FPG and body weight. Dose changes of basal and short-acting insulin were small in both groups, but higher in the Gla-300 group than in the Deg-100 group ( p < 0.006). Incidence rates (IR) of hypoglycemia (blood glucose ≤ 70 mg/dl and < 54 mg/dl) during the 6-month follow-up by treatment were slightly lower in the Gla-300 group than in the Deg-100 group [IR ratios 0.82 (95% CI 0.55; 1.22) and 0.83; (95% CI 0.38; 1.83), respectively]. Hypoglycemic events (blood glucose < 54 mg/dl) decreased at 6 months in both groups ( p = 0.01 for Gla-300 and p < 0.001 for IDeg-100). There were no severe hypoglycemic events for Gla-300 and seven events for IDeg-100 ( p = 0.02). Conclusions Switching from 1BI to 2BI in adults with T1D was associated with similar improvements in glycemic control and overall significant decrease in hypoglycemia, with no severe events with Gla-300. Effectiveness of both insulins was limited by under-titration. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-020-00982-z.

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The importance of the initial period of basal insulin titration in people with diabetes

Cited by 26 publications

References 62 publications

Gestione iniziale della terapia con insulina basale nel paziente diabetico

Gestione iniziale della terapia con insulina basale nel paziente diabetico

Second‐generation basal insulins to initiate insulin therapy in type 2 diabetes: A need for clinical evidence before incurring increased costs

Comparative Effectiveness of Switching From First-Generation Basal Insulin to Glargine 300 U/ml or Degludec 100 U/ml in Type 1 Diabetes: The RESTORE-1 Study

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