| Autor: |
Bebakar WM; School of Medical Sciences Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia. wanmohd@usm.my., Chaykin L; Meridien Research, 5700 E State Road 64, Bradenton, FL, 34208, USA., Hersløv ML; Novo Nordisk A/S, Vandtaarnsvej 114, 2860, Søborg, Denmark., Rasmussen S; Novo Nordisk A/S, Vandtaarnsvej 114, 2860, Søborg, Denmark. |
| Jazyk: |
angličtina |
| Zdroj: |
Diabetes therapy : research, treatment and education of diabetes and related disorders [Diabetes Ther] 2017 Feb; Vol. 8 (1), pp. 197-205. Date of Electronic Publication: 2016 Nov 16. |
| DOI: |
10.1007/s13300-016-0213-8 |
| Abstrakt: |
Introduction: In a preceding trial comparing two different titration schemes, insulin degludec/insulin aspart (IDegAsp) showed good efficacy for achieving HbA 1c <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 HbA 1c ≤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 HbA 1c 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 HbA 1c 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 HbA 1c <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 HbA 1c during 26-week IDegAsp BID treatment, HbA 1c 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. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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