Prospektywna ocena skuteczności i bezpieczeństwa insuliny glargine 100 U / ml (Gla-100) u dorosłych chorych na cukrzycę w Polsce: badanie obserwacyjne LARE
| Autor: | Grzegorz Dzida, Tomasz Szczepanik |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
endocrine system diseases business.industry Insulin glargine Endocrinology Diabetes and Metabolism Insulin medicine.medical_treatment nutritional and metabolic diseases Type 2 Diabetes Mellitus NPH insulin Hypoglycemia medicine.disease Lower risk Diabetes mellitus Internal medicine Internal Medicine Medicine business medicine.drug Glycemic |
| Zdroj: | Clinical Diabetology. |
| ISSN: | 2450-8187 2450-7458 |
| DOI: | 10.5603/dk.a2021.0015 |
| Popis: | Introduction. Insulin glargine 100 U/ml (Gla-100) is a long-lasting basal insulin analog injected once daily. This real-life study aimed to evaluate the efficacy and safety of Gla-100 in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM), who were recently switched from isophane (NPH) insulin. Methods. This multicenter, prospective, 52-week observational study included 321 patients with T1DM and 766 with T2DM. The primary endpoint was the percentage of participants with a HbA 1c reduction of ≥ 0.5% at 52 weeks. The secondary endpoints included fasting plasma glucose (FPG) and HbA1c reduction over time, and hypoglycemic events. Results. Of the 1,087 patients included, 69.9% achieved the primary endpoint, while the mean HbA 1c decreased by 1.03% and the mean FPG by 31.8 mg/dL at 52 weeks. The average annual rate of severe hypoglycemia was 0.017 events per patient-year and 0.82 events per patient-year for nocturnal hypoglycemia. The proportion of participants experiencing severe diurnal or nocturnal hypoglycemia was significantly lower in the four weeks prior to the study end than the four weeks before the switch from NPH insulin (p |
| Databáze: | OpenAIRE |
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