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16.11.2016 | Brief Report | Ausgabe 1/2017 Open Access

Diabetes Therapy 1/2017

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

Zeitschrift:
Diabetes Therapy > Ausgabe 1/2017
Autoren:
Wan Mohamaed Wan Bebakar, Louis Chaykin, Malene Lundgren Hersløv, Søren Rasmussen
Wichtige Hinweise

Electronic supplementary material

The 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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Abstract

Introduction

In 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).

Method

A 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).

Results

Mean 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.

Conclusion

When 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.

Funding

Novo Nordisk.

Clinicaltrials.gov identifier

NCT01814137.
Zusatzmaterial
Supplementary material 1 (DOCX 13 kb)
13300_2016_213_MOESM1_ESM.docx
Literatur
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