Published in:
Open Access
01-12-2018 | Original Research
Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
Authors:
Paola Ponzani, Cesare Berra, Alessandra Di Lelio, Paola Del Sindaco, Chiara Di Loreto, Francesco Reggiani, Giuseppe Lucisano, Maria Chiara Rossi
Published in:
Diabetes Therapy
|
Issue 6/2018
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Abstract
Introduction
Real-world evidence on effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. The aim of the study was to evaluate patterns of use and the long-term effectiveness and safety of IDeg in routine clinical practice.
Methods
This was an observational longitudinal study. A retrospective chart review of all patients with type 2 diabetes treated with IDeg was performed and temporal trends in clinical outcomes were assessed. All data was stratified by treatment modality: the switch group consisted of patients already treated with another basal insulin before initiating IDeg; the add-on group consisted of basal insulin-naïve patients.
Results
Overall, 247 patients were analyzed (55 in the add-on group and 192 in the switch group), mean age 67.0 ± 10.9 years ,and diabetes duration 16.3 ± 8.9 years. Median (interquartile range) follow-up was 9.7 (8.0–11.9) months. In the add-on group, improvements were found in glycated hemoglobin (HbA1c) (– 1.68%; p < 0.0001), fasting blood glucose (FBG) (– 64.7 mg/dL; p < 0.0001), post-prandial glucose (PPG) (– 81.1 mg/dl; p < 0.0001), and glycemic variability (i.e., standard deviation of blood glucose) (– 11.6 mg/dl; p = 0.04). Even in the switch group, improvements were found in HbA1c (– 0.57%; p < 0.0001), FBG (– 28.1 mg/dL; p < 0.0001), and PPG (– 22.6 mg/dl; p = 0.001). Body weight increase during the follow-up was not statistically significant vs. baseline in both groups. Benefits on overall, nocturnal, and severe hypoglycemia were found in the switch group.
Conclusion
These real-world data documented that initiating IDeg or switching to IDeg from other basal insulins in type 2 diabetes was associated with significant improvement in metabolic control without significant weight gain; a decrease in the risk of hypoglycemia was observed when switching to IDeg from another basal insulin.