Treatment intensification with an insulin degludec (<scp>IDeg</scp>)/insulin aspart (<scp>IAsp</scp>) co‐formulation twice daily compared with basal <scp>IDeg</scp> and prandial <scp>IAsp</scp> in type 2 diabetes: a randomized, controlled phase <scp>III</scp> trial

Rodbard, Helena W.; Cariou, Bertrand; Pieber, Thomas R.; Endahl, Lars; Zacho, Jeppe; Cooper, John G.

doi:10.1111/dom.12609

Cited by 35 publications

(66 citation statements)

References 27 publications

(48 reference statements)

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“…The frequency of AEs observed during treatment was similar in both treatments and in line with existing trials, with few severe hypoglycemic episodes being reported and no new safety issues being identified [4–8]. …”

Section: Discussionsupporting

confidence: 79%

“…After 26 weeks of IDegAsp BID treatment, 67% of patients successfully achieved the recommended HbA 1c target of less than 7%, accompanied by significant reductions in fasting plasma glucose (FPG), while rates of hypoglycemia were in line with previous trials of intensification with IDegAsp BID [4–8]. …”

Section: Introductionsupporting

confidence: 73%

“…In previous IDegAsp clinical trials, patients with T2D inadequately controlled on OADs plus an alternative insulin regimen (i.e., basal-only insulin detemir, insulin glargine administered OD or BID; a premix, analogue insulin regimen administered BID; or an insulin regimen containing a rapid-acting component) have shown similar reduction in HbA 1c and fewer hypoglycemic episodes following intensification with IDegAsp BID versus comparator regimens (i.e., basal–prandial, premix BID)—with the responder rate for HbA 1c <7% following IDegAsp BID treatment ranging from 48.2% to 56.5% [4–6, 8]. In the preceding titration trial comparing a simple vs. stepwise titration of IDegAsp BID in patients previously inadequately controlled on basal insulin, the overall responder rate for intensification with IDegAsp BID was 67% [7], which is higher than that seen in the earlier studies [4–6, 8].…”

Section: Discussionmentioning

confidence: 99%

“…In the preceding titration trial comparing a simple vs. stepwise titration of IDegAsp BID in patients previously inadequately controlled on basal insulin, the overall responder rate for intensification with IDegAsp BID was 67% [7], which is higher than that seen in the earlier studies [4–6, 8]. …”

Section: Discussionmentioning

confidence: 99%

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Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal–Bolus): Exploratory Randomized Trial in Type 2 Diabetes

et al. 2016

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IntroductionIn a preceding trial comparing two different titration schemes, insulin degludec/insulin aspart (IDegAsp) showed good efficacy for achieving HbA1c <7% when administered twice daily (BID) in patients with uncontrolled type 2 diabetes (T2D). However, poor glycemic control persisted in a minority of patients. The current exploratory trial investigated the efficacy and safety of intensifying IDegAsp BID treatment in these patients by either adding a once-daily (OD) bolus injection of insulin aspart (IAsp) or by switching to a basal–bolus regimen of insulin degludec (IDeg) plus IAsp taken three times a day (TID).MethodA 26-week, randomized, open-label, phase 3b, treat-to-target trial in which 40 patients with T2D who had not reached target HbA1c ≤7.0% following previous 26-week treatment intensification with IDegAsp BID ±3 oral antidiabetic agents (OADs) were randomized (1:1) to receive IDegAsp BID + IAsp OD (n = 20) or IDeg OD + IAsp TID (n = 20).ResultsMean baseline HbA1c was 7.9% in the IDegAsp BID + IAsp OD group and 7.7% in the IDeg OD + IAsp TID group. After 26 weeks, the estimated mean change in HbA1c from baseline was 0.05% points in the IDegAsp BID + IAsp OD group and −0.49% points for IDeg OD + IAsp TID: estimated treatment difference (ETD) [95% confidence interval] 0.54% [0.09; 0.99], p = 0.021. Few achieved HbA1c <7% in IDegAsp BID + IAsp OD (four patients) and IDeg OD + IAsp TID groups (five patients). Fasting plasma glucose, hypoglycemia, and adverse events were similar between groups.ConclusionWhen used as intensification regimens in patients who failed to achieve target HbA1c during 26-week IDegAsp BID treatment, HbA1c improvements were numerically greater with IDeg OD + IAsp TID compared with IDegAsp BID + IAsp OD. No new safety issues were identified. However, the small, selective sample means clinical generalizations should be made with caution.FundingNovo Nordisk.Clinicaltrials.gov identifierNCT01814137.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-016-0213-8) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 79%

Section: Introductionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal–Bolus): Exploratory Randomized Trial in Type 2 Diabetes

et al. 2016

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“…Comparing two treatment‐optimisation regimens from basal‐only therapy, IDegAsp (twice‐daily) showed final HbA 1c comparable to the one achieved with a meal‐time + basal regimen of IDeg + IAsp (7.0% and 6.8%, NS) . Although non‐inferiority for IDegAsp was not achieved, insulin dose was 12% lower using combination insulin, while both confirmed and nocturnal hypoglycaemia rates were 19% and 20% lower respectively (Table ) .…”

Section: Clinical Evidence In T2dmmentioning

confidence: 96%

Clinical use of the co-formulation of insulin degludec and insulin aspart

et al. 2016

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Summary Aims To provide a review of the available data and practical use of insulin degludec with insulin aspart (IDegAsp). Premixed insulins provide basal and prandial glucose control; however, they have an intermediate‐acting prandial insulin component and do not provide as effective basal coverage as true long‐acting insulins, owing to the physicochemical incompatibility of their individual components, coupled with the inflexibility of adjustment. The molecular structure of the co‐formulation of IDegAsp, a novel insulin preparation, allows these two molecules to coexist without affecting their individual pharmacodynamic profiles. Methods Clinical evidence in phase 2/3 trials of IDegAsp efficacy and safety in type 1 and type 2 diabetes mellitus (T1DM and T2DM) have been assessed and summarised. Results In people with T2DM, once‐ and twice‐daily dosing provides similar overall glycaemic control (HbA1c) to current modern insulins, but with lower risk of nocturnal hypoglycaemia. In prior insulin users, glycaemic control was achieved with lower or equal insulin doses vs. other basal+meal‐time or premix insulin regimens. In insulin‐naïve patients with T2DM, IDegAsp can be started once or twice‐daily, based on individual need. People switching from more than once‐daily basal or premix insulin therapy can be converted unit‐to‐unit to once‐daily IDegAsp, although this strategy should be assessed by the physician on an individual basis. Conclusions IDegAsp offers physicians and people with T2DM a simpler insulin regimen than other available basal‐bolus or premix‐based insulin regimens, with stable daytime basal coverage, a lower rate of hypoglycaemia and some flexibility in injection timing compared with premix insulins.

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Multinational Consensus: Insulin Initiation with Insulin Degludec/Aspart (IDegAsp)

et al. 2018

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Insulin degludec/aspart (IDegAsp) is the first soluble insulin co-formulation, combining a long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). In type 2 diabetes patients with oral antidiabetes agent (OAD) inadequacy, insulin initiation with IDegAsp once daily provides superior long-term glycemic control compared to insulin glargine, with similar fasting plasma glucose (FPG) and insulin doses, and numerically lower rates of overall and nocturnal hypoglycemia. Furthermore, in patients with uncontrolled type 2 diabetes previously treated with insulins, IDegAsp twice daily effectively improves glycated hemoglobin and FPG, with fewer hypoglycemic episodes versus premix insulins and basal bolus therapy. In patients with type 1 diabetes mellitus, IDegAsp once daily with two doses of IAsp is a convenient, yet effective, regimen as compared to the conventional 4-5 injection-based basal bolus therapy. IDegAsp is an appropriate and reasonable option for initiation of insulin therapy in both type 1 and type 2 diabetes.

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Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co‐formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial

Cited by 35 publications

References 27 publications

Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal–Bolus): Exploratory Randomized Trial in Type 2 Diabetes

Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal–Bolus): Exploratory Randomized Trial in Type 2 Diabetes

Clinical use of the co-formulation of insulin degludec and insulin aspart

Multinational Consensus: Insulin Initiation with Insulin Degludec/Aspart (IDegAsp)

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