基礎胰島素類似物 Gla-100 與 IDeg-100 低血糖機率比較

Insulin Degludec = IDeg-100 第二代基礎胰島素類似物
Insulin Glargine U100= Gla-100 第一代基礎胰島素類似物

Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial.  JAMA. 2017;318(1):45.

將病患分成兩組, 一組打 Gla-100, 另一組打 IDeg-100, 兩組都花 16 周調整藥物劑量, 接著以維持劑量治療 16 周,
Importance Hypoglycemia, a serious risk for insulin-treated patients with type 2 diabetes, negatively affects glycemic control.
Objective To test whether treatment with basal insulin degludec is associated with a lower rate of hypoglycemia compared with insulin glargine U100 in patients with type 2 diabetes.
Design, Setting, and Participants Randomized, double-blind, treat-to-target crossover trial including two 32-week treatment periods, each with a 16-week titration period and a 16-week maintenance period. The trial was conducted at 152 US centers between January 2014 and December 2015 in 721 adults with type 2 diabetes and at least 1 hypoglycemia risk factor who were previously treated with basal insulin with or without oral antidiabetic drugs.

低血糖定義, 血糖 < 56
夜間低血糖量測兩個時間, 半夜 12 點 01分以及早上 5點59分.
Interventions Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 361) or to receive insulin glargine U100 followed by insulin degludec (n = 360) and randomized 1:1 to morning or evening dosing within each treatment sequence.
Main Outcomes and Measures The primary end point was the rate of overall symptomatic hypoglycemic episodes (severe or blood glucose confirmed [<56 mg/dL]) during the maintenance period. Secondary end points were the rate of nocturnal symptomatic hypoglycemic episodes (severe or blood glucose confirmed, occurring between 12:01 am and 5:59 am) and the proportion of patients with severe hypoglycemia during the maintenance period.

收錄 721 位病患, 580位 完成研究, IDeg-100 與 Gla-100 比較
有症狀低血糖事件 185.6 比 265.4 (每100位病患,每年)
整體發生低血糖的病患 22.5% 比 31.6%
夜間有症狀低血糖 55.2 比 93.6 件 (每100位病患每年)
夜間有症狀低血糖病患數量 9.7% 比 14.7%
嚴重低血糖 1.6% 比 2.4%

整體有症狀低血糖. 與有症狀夜間低血糖機率, 使用 IDeg-100 顯著減少.

Results Of the 721 patients randomized (mean [SD]age, 61.4 [10.5]years; 53.1% male), 580 (80.4%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 were 185.6 vs 265.4 episodes per 100 patient-years of exposure (PYE) (rate ratio = 0.70 [95% CI, 0.61-0.80]; P < .001; difference, -23.66 episodes/100 PYE [95% CI, -33.98 to -13.33]), and the proportions of patients with hypoglycemic episodes were 22.5% vs 31.6% (difference, -9.1% [95% CI, -13.1% to -5.0%]). The rates of nocturnal symptomatic hypoglycemia with insulin degludec vs insulin glargine U100 were 55.2 vs 93.6 episodes/100 PYE (rate ratio = 0.58 [95% CI, 0.46-0.74]; P < .001; difference, -7.41 episodes/100 PYE [95% CI, -11.98 to -2.85]), and the proportions of patients with hypoglycemic episodes were 9.7% vs 14.7% (difference, -5.1% [95% CI, -8.1% to -2.0%]). The proportions of patients experiencing severe hypoglycemia during the maintenance period were 1.6% (95% CI, 0.6%-2.7%) for insulin degludec vs 2.4% (95% CI, 1.1%-3.7%) for insulin glargine U100 (McNemar P = .35; risk difference, -0.8% [95% CI, -2.2% to 0.5%]). Statistically significant reductionsin overall and nocturnal symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 were also seen for the full treatment period.
Conclusions and Relevance Among patients with type 2 diabetes treated with insulin and with at least 1 hypoglycemia risk factor, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemia.