Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre‐planned meta‐analysis of phase 3 trials

Ratner, Robert E.; Gough, S; Mathieu, Chantal; Prato, Stefano Del; Bode, Bruce W.; Mersebach, Henriette; Endahl, Lars; Zinman, Bernard

doi:10.1111/dom.12032

Cited by 317 publications

(357 citation statements)

References 27 publications

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“…The design of this post hoc analysis, including the segmentation of the overall trial period into titration (0-15 weeks) and maintenance (16-26 weeks) periods, matched that of an earlier preplanned meta-analysis of all IDeg phase 3a clinical trials (16).…”

Section: Statistical Analysesmentioning

confidence: 99%

“…The IDeg component in IDegAsp has been demonstrated to have a predictable glucose-lowering effect and up to four times lower day-to-day variability compared with insulin glargine at steadystate conditions (15). Clinical trials have demonstrated a lower risk of IDeg causing hypoglycemia compared with insulin glargine (16) and the possibility of flexibility in the timing of injections (17).…”

mentioning

confidence: 99%

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Comparison of Insulin Degludec/Insulin Aspart and Biphasic Insulin Aspart 30 in Uncontrolled, Insulin-Treated Type 2 Diabetes: A Phase 3a, Randomized, Treat-to-Target Trial

et al. 2014

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OBJECTIVEInsulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once-or twice-daily (OD or BID) pre-or self-mixed insulin with or without oral antidiabetic drugs. RESEARCH DESIGN AND METHODSIn this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m 2 , and HbA 1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L. RESULTSAfter 26 weeks, mean HbA 1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA 1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30. CONCLUSIONSIDegAsp BID effectively improves HbA 1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once-or twice-daily pre-or self-mixed insulin.

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Section: Statistical Analysesmentioning

confidence: 99%

mentioning

confidence: 99%

Comparison of Insulin Degludec/Insulin Aspart and Biphasic Insulin Aspart 30 in Uncontrolled, Insulin-Treated Type 2 Diabetes: A Phase 3a, Randomized, Treat-to-Target Trial

et al. 2014

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“…In the population of subjects with T2DM, the rates of overall and nocturnal confirmed hypoglycemia were: 17% and 32% lower, respectively, across the entire treatment period; 25% and 38%, respectively, during the maintenance phase. 15 This pre-planned meta-analysis shows that similar improvements in HbA1c can be achieved with fewer hypoglycemic episodes, particularly nocturnal episodes, with IDeg than with IGlar across a broad spectrum of patients with diabetes (particularly T2DM patients), and insulin regimens. 15 Long-acting insulin analogues have been developed to cover the basal requirements of patients with diabetes but current treatment options generally require sometime-daily (or even twice-daily) administration to ensure optimal glycemic control.…”

Section: Efficacy and Safety Of Insulin Degludec In Subjects With Diamentioning

confidence: 83%

“…15 This pre-planned meta-analysis shows that similar improvements in HbA1c can be achieved with fewer hypoglycemic episodes, particularly nocturnal episodes, with IDeg than with IGlar across a broad spectrum of patients with diabetes (particularly T2DM patients), and insulin regimens. 15 Long-acting insulin analogues have been developed to cover the basal requirements of patients with diabetes but current treatment options generally require sometime-daily (or even twice-daily) administration to ensure optimal glycemic control. This schedule is often in conflict with everyday variations in patients' lives and can be challenging for patients.…”

Section: Efficacy and Safety Of Insulin Degludec In Subjects With Diamentioning

confidence: 83%

Inpatient hyperglycemia management: the opportunities of a new basal insulin

Simioni¹

2016

Ital J Med

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The management of hospitalized diabetic patients for any cause is often difficult and affected not only by the comorbidities of the patient but also by the hospital setting. It is well known that at the admission the antidiabetic drugs should be discontinued on behalf of insulin therapy with insulin analogues, as a function of a basal-bolus insulin approach according to the phenotype of the patient, type of nutrition (enteral or parenteral rather than oral), or concomitant hyperglycemic therapy (e.g., steroid). The average stay of diabetic patients hospitalized for any cause is significantly correlated with both the number of hypoglycemia and hyperglycemia. Compared to patients treated with sliding scale patients using a custom algorithm show a significant reduction in the number of hypoglycemia and hyperglycemia episodes and in the length of stay. We analyze the clinical profile of a novel basal insulin, degludec, and explore the potential clinical benefit for diabetic inpatient. The continuation of insulin therapy at home in the immediate post-hospitalization (if necessary), also correlates with a reduction in the rate of re-hospitalization, which combined with close follow-up diabetes can result in a reduction of chronic complications.

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“…Insulin degludec has been clearly demonstrated to be equivalent to insulin glargine in lowering HbA 1c in key RCTs in both type 1 and type 2 diabetes (14,23,24). However, the risk of hypoglycemia, especially nocturnal hypoglycemia, was further reduced by ;25% during the maintenance period of the trials despite somewhat lower fasting plasma glucose concentrations (40). In addition, insulin degludec allows a more flexible approach to the timing of insulin administration to better accommodate the recipients' ever-changing daily life pattern (1,3,4,10,13,50,54).…”

Section: Arguments In Favor Of the New Insulinsmentioning

confidence: 99%