Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL in People with Type 1 Diabetes on Basal–Bolus Insulin: Phase 4 OPTIMIZE Study
Autor: | Peter Stella, S. John Weisnagel, Chantal Mathieu, Jacques Bruhwyler, Kathy C. Alexandre |
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Rok vydání: | 2020 |
Předmět: |
medicine.medical_specialty
Insulin glargine Endocrinology Diabetes and Metabolism medicine.medical_treatment 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Bedtime Gastroenterology 03 medical and health sciences Diabetes mellitus 0302 clinical medicine Blood glucose self-monitoring Internal medicine Blood Glucose Self-Monitoring Internal Medicine medicine Clinical endpoint Original Research Type 1 diabetes business.industry Insulin Repeated measures design Patient satisfaction medicine.disease Clinical trial Phase IV business Type 1 medicine.drug |
Zdroj: | Diabetes Therapy |
ISSN: | 1869-6961 1869-6953 |
Popis: | Introduction OPTIMIZE evaluated the efficacy, safety and treatment satisfaction of insulin glargine 300 U/mL once daily (Gla-300 OD) in people with type 1 diabetes mellitus (T1DM) previously uncontrolled on basal insulin twice daily (BID) as part of basal–bolus therapy. Methods OPTIMIZE was a 28-week, prospective, interventional, single-arm phase 4 trial in adults with T1DM. At baseline, basal insulin BID treatment was switched to Gla-300 OD titrated to a fasting self-monitored blood glucose target of 4.4–7.2 mmol/L (80–130 mg/dL). The primary endpoint was the mean glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary endpoints included self-monitored blood glucose, fasting-plasma glucose, hypoglycaemia and patient-reported outcomes including the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs). Results Switching to Gla-300 OD significantly improved mean HbA1c (8.54% at baseline and 8.27% at week 24 [last observation carried forward, N = 94, p |
Databáze: | OpenAIRE |
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