학술논문
Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study
CLINICAL RESEARCH ARTICLE
CLINICAL RESEARCH ARTICLE
Document Type
Academic Journal
Author
Source
Journal of Clinical Endocrinology & Metabolism. December 2019, Vol. 104 Issue 12, p5977, 14 p.
Subject
Language
English
ISSN
0021-972X
Abstract
Hypoglycemia is a common treatment-related event among patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) treated with insulin and is often a key barrier to obtaining good [...]
Context: Observational studies of insulin degludec (degludec) with hypoglycemia events prospectively recorded are lacking. Objective: To evaluate the safety and effectiveness of degludec in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) switching from other basal insulins in routine care. Design: Results From Real-World Clinical Treatment With Tresiba[R] was a multinational, multicenter, prospective, observational, single-arm study comprising a 4-week baseline period (preswitch basal insulin) and 12-month follow-up (degludec). Setting: Routine clinical practice. Patients or Other Participants: Insulin-treated patients ([greater than or equal to]18 years) with T1D (n = 556) or T2D (n = 611) with treatment plans to initiate degludec. Interventions: Switching to degludec from other basal insulins. Main Outcome Measure: Change from baseline in number of overall hypoglycemic events recorded in patient diaries. Results: In T1D, the 12-month follow-up/baseline rate ratios (95% CI) of overall [0.80 (0.74 to 0.88)], nonsevere [0.83 (0.76 to 0.91)], severe [0.28 (0.14 to 0.56)], and nocturnal [0.61 (0.50 to 0.73)] hypoglycemia suggested significantly lower hypoglycemia rates with degludec (all Ps, 0.001). At 12 months, HbA1c, fasting plasma glucose (FPG), and basal insulin dosage decreased significantly. Body weight increased, and treatment satisfaction improved significantly. In T2D, the hypoglycemia rate ratios were overall [0.46 (0.38 to 0.56)], nonsevere [0.53 (0.44 to 0.64)], and nocturnal [0.35 (0.20 to 0.62)] (all Ps, 0.001; too few events for analysis of severe hypoglycemia). At 12 months, HbA1c and FPG decreased significantly. Body weight and insulin dosages remained unchanged, and treatment satisfaction was significantly improved. Conclusions: In a routine clinical care setting, switching to degludec from other basal insulins was associated with significantly lower rates of hypoglycemia, improved glycemic control, and treatment satisfaction in patients with T1D or T2D. (J Clin Endocrinol Metab 104: 5977-5990, 2019)
Context: Observational studies of insulin degludec (degludec) with hypoglycemia events prospectively recorded are lacking. Objective: To evaluate the safety and effectiveness of degludec in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) switching from other basal insulins in routine care. Design: Results From Real-World Clinical Treatment With Tresiba[R] was a multinational, multicenter, prospective, observational, single-arm study comprising a 4-week baseline period (preswitch basal insulin) and 12-month follow-up (degludec). Setting: Routine clinical practice. Patients or Other Participants: Insulin-treated patients ([greater than or equal to]18 years) with T1D (n = 556) or T2D (n = 611) with treatment plans to initiate degludec. Interventions: Switching to degludec from other basal insulins. Main Outcome Measure: Change from baseline in number of overall hypoglycemic events recorded in patient diaries. Results: In T1D, the 12-month follow-up/baseline rate ratios (95% CI) of overall [0.80 (0.74 to 0.88)], nonsevere [0.83 (0.76 to 0.91)], severe [0.28 (0.14 to 0.56)], and nocturnal [0.61 (0.50 to 0.73)] hypoglycemia suggested significantly lower hypoglycemia rates with degludec (all Ps, 0.001). At 12 months, HbA1c, fasting plasma glucose (FPG), and basal insulin dosage decreased significantly. Body weight increased, and treatment satisfaction improved significantly. In T2D, the hypoglycemia rate ratios were overall [0.46 (0.38 to 0.56)], nonsevere [0.53 (0.44 to 0.64)], and nocturnal [0.35 (0.20 to 0.62)] (all Ps, 0.001; too few events for analysis of severe hypoglycemia). At 12 months, HbA1c and FPG decreased significantly. Body weight and insulin dosages remained unchanged, and treatment satisfaction was significantly improved. Conclusions: In a routine clinical care setting, switching to degludec from other basal insulins was associated with significantly lower rates of hypoglycemia, improved glycemic control, and treatment satisfaction in patients with T1D or T2D. (J Clin Endocrinol Metab 104: 5977-5990, 2019)