A Novel Insulin Combination of Insulin Degludec and Insulin Aspart Achieves a More Stable Overnight Glucose Profile Than Insulin Glargine: Results from Continuous Glucose Monitoring in a Proof-of-Concept Trial

Liebl, Andreas; Davidson, Jaime A.; Mersebach, Henriette; Dykiel, Patrik; Tack, Cees J.; Heise, Tim

doi:10.1177/193229681300700524

Cited by 29 publications

(43 citation statements)

References 18 publications

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“…In the current study series, once-daily IDegAsp gave, as expected, superior performance to IGlar alone in insulin-naïve people, without detriment in terms of hypoglycemia despite the improved postmain-meal glucose control [44]. Here, the finding by continuous glucose monitoring of lower glycemic excursions during the night appears to be consistent with the clamp findings of low within-day variability compared with IGlar [42].…”

Section: Expert Commentarysupporting

confidence: 79%

“…The trend of lower hypoglycemia rates in phase 2 trials was later observed in phase 3 trials (Table 2). A supplementary continuous glucose monitoring study, performed in the last 3 days before the 16-week end point, found a 21% reduction in hypoglycemic nocturnal glucose excursions (area under the curve) with IDegAsp than with IGlar in people with T2DM [42].…”

Section: Phase 2 Clinical Trialsmentioning

confidence: 99%

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IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

Christiansen

Home

Kumar

2016

Expert Review of Endocrinology & Metabolism

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SUMMARYThe co-formulation insulin degludec/insulin aspart (IDegAsp) contains insulin degludec (IDeg), a basal insulin, and the rapid-acting insulin aspart (IAsp). Its unique pharmacodynamic profile provides a stable basal insulin action over a 24-h period due to the flat, ultra-long effect of IDeg, combined with prandial control from IAsp, which is unaffected by the basal component. IDegAsp provides a distinct mealtime insulin peak effect and reduces the likelihood of postprandial glucose excursions. The phase 2 and 3 clinical trial program demonstrates that IDegAsp provides effective glycemic control with lower rates of hypoglycemia compared with the current standard of care for insulins. Compared with premixed insulin formulations, IDegAsp allows mealtime flexibility, enabling the time of injection to be adjusted to a different meal(s) on a daily basis to suit changing needs, and has the potential to improve adherence rates. IDegAsp offers a promising new insulin strategy for the treatment of type 2 diabetes.ARTICLE HISTORY

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Section: Expert Commentarysupporting

confidence: 79%

Section: Phase 2 Clinical Trialsmentioning

confidence: 99%

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

Christiansen

Home

Kumar

2016

Expert Review of Endocrinology & Metabolism

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“…The IDegAsp treatment was associated with flatter and more stable nightly glucose profiles than those observed with IGlar. The observed mean fluctuation in nocturnal IG was 1.13 versus 1.30 mmol/L with IDegAsp and IGlar 76. Nocturnal rates of high IG episodes were 48% lower with IDegAsp, while the rates of nocturnal low interstitial glucose levels did not differ between groups 76.…”

Section: Idegasp: Overview Of Clinical Pharmacology Trialstype 1 Diabmentioning

confidence: 82%

“…The observed mean fluctuation in nocturnal IG was 1.13 versus 1.30 mmol/L with IDegAsp and IGlar 76. Nocturnal rates of high IG episodes were 48% lower with IDegAsp, while the rates of nocturnal low interstitial glucose levels did not differ between groups 76. As expected, IDegAsp was associated with reduced postdinner IG excursions (IDegAsp/IGlar, −1.42 mmol/L [−2.15, −0.70] mmol/L).…”

Section: Idegasp: Overview Of Clinical Pharmacology Trialstype 1 Diabmentioning

confidence: 83%

Insulin degludec/insulin aspart combination for the treatment of type 1 and type 2 diabetes

Dardano¹,

Bianchi²,

Prato³

et al. 2014

VHRM

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Glycemic control remains the major therapeutic objective to prevent or delay the onset and progression of complications related to diabetes mellitus. Insulin therapy represents a cornerstone in the treatment of diabetes and has been used widely for achieving glycemic goals. Nevertheless, a large portion of the population with diabetes does not meet the internationally agreed glycemic targets. Moreover, insulin treatment, especially if intensive, may be associated with emergency room visits and hospitalization due to hypoglycemic events. Therefore, fear of hypoglycemia or hypoglycemic events represents the main barriers to the attainment of glycemic targets. The burden associated with multiple daily injections also remains a significant obstacle to initiating and maintaining insulin therapy. The most attractive insulin treatment approach should meet the patients’ preference, rather than demanding patients to change or adapt their lifestyle. Insulin degludec/insulin aspart (IDegAsp) is a new combination, formulated with ultra-long-acting insulin degludec and rapid-acting insulin aspart, with peculiar pharmacological features, clinical efficacy, safety, and tolerability. IDegAsp provides similar, noninferior glycemic control to a standard basal–bolus regimen in patients with type 1 diabetes mellitus, with additional benefits of significantly lower episodes of hypoglycemia (particularly nocturnal) and fewer daily insulin injections. Moreover, although treatment strategy and patients’ viewpoint are different in type 1 and type 2 diabetes, trial results suggest that IDegAsp may be an appropriate and reasonable option for initiating insulin therapy in patients with type 2 diabetes inadequately controlled on maximal doses of conventional oral agents. This paper will discuss the role of IDegAsp combination as a novel treatment option in diabetic patients.

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“…CGM has been used in RCTs to compare Gla‐100 and IDet, and IDeg, in combination with insulin aspart, and Gla‐300; however, such trials predominantly focus on comparisons of glycaemic variability. For example, the study by Bergenstal et al, which used CGM to compare Gla‐100 and Gla‐300, defined hypoglycaemia events using only the traditional methods of SMBG confirmation .…”

Section: Diversity Of Hypoglycaemia Assessment and Reporting In Randomentioning

confidence: 99%

Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus

Frier

Ratzki‐Leewing

Harris

2019

Diabetes Obesity Metabolism

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Hypoglycaemia is a common side‐effect of diabetes therapies, particularly insulin, and imposes a substantial burden on individuals and healthcare systems. Consequently, regulatory approval of newer basal insulin (BI) therapies has relied on demonstration of a balance between achievement of good glycaemic control and less hypoglycaemia. Randomized controlled trials (RCTs) are the gold standard for assessing efficacy and safety, including hypoglycaemia risk, of BIs and are invaluable for obtaining regulatory approval. However, their highly selected patient populations and their conditions lead to results that may not be representative of real‐life situations. Real‐world evidence (RWE) studies are more representative of clinical practice, but they also have limitations. As such, data both from RCTs and RWE studies provide a fuller picture of the hypoglycaemia risk with BI therapies. However, substantial differences exist in the way hypoglycaemia is reported across these studies, which confounds comparisons of hypoglycaemia frequency among different BIs. This problem is ongoing and persists in recent trials of second‐generation BI analogues. Although they provide a lower risk of hypoglycaemia when compared with earlier BIs, they do not eliminate it. This review describes differences in the way hypoglycaemia is reported across RCTs and RWE studies of second‐generation BI analogues and examines potential reasons for these differences. For studies of BIs, there is a need to standardize aspects of design, analysis and methods of reporting to better enable interpretation of the efficacy and safety of such insulins among studies; such aspects include length of follow‐up, glycaemic targets, hypoglycaemia definitions and time intervals for determining nocturnal events.

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A Novel Insulin Combination of Insulin Degludec and Insulin Aspart Achieves a More Stable Overnight Glucose Profile Than Insulin Glargine: Results from Continuous Glucose Monitoring in a Proof-of-Concept Trial

Cited by 29 publications

References 18 publications

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

Insulin degludec/insulin aspart combination for the treatment of type 1 and type 2 diabetes

Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus

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