Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension.
Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension.
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DOI：
10.1210/jc.2012-3249
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发表时间：
2013-03
期刊：
影响因子：
--
通讯作者：
NN1250-3770 (BEGIN: Flex T1) Trial Investigators
中科院分区：
文献类型：
--
作者：
Mathieu C;Hollander P;Miranda-Palma B;Cooper J;Franek E;Russell-Jones D;Larsen J;Tamer SC;Bain SC;NN1250-3770 (BEGIN: Flex T1) Trial Investigators
本研究探讨了1型糖尿病患者每日一次（OD）不同注射时间的degludec胰岛素（IDeg）的有效性和安全性。这项为期26周、开放标签、从治疗到靶点的非效性试验比较了IDeg强制柔性（forced - flex） OD（按固定时间表给药，每次给药间隔至少8小时和最多40小时）与IDeg或甘精胰岛素（IGlar）每日同一时间给药。在26周的延长中，所有IDeg受试者被转移到自由灵活（Free-Flex）方案，该方案允许在一天中的任何时间给药，并与继续使用IGlar的受试者进行比较。治疗26周后，IDeg Forced- Flex（- 0.40%）、IDeg（- 0.41%）和IGlar（- 0.58%）降低了平均糖化血红蛋白。实现了IDeg强制挠性非劣效性。空腹血糖降低与IDeg Forced-Flex和IGlar相似，但IDeg （- 2.54 mmol/L）高于IDeg Forced-Flex (- 1.28 mmol/L) （P = 0.021）。在第52周，IDeg Free-Flex受试者的糖化血红蛋白与IGlar受试者相似，但空腹血糖降低幅度更大（- 1.07 mmol/L） （P = 0.005）。确认的低血糖率（血浆葡萄糖<3.1 mmol/L或严重低血糖）在26周和52周相似。第26周时，IDeg - flex与IDeg （37%, P = 0.003）和IGlar （40%, P = 0.001）组夜间确诊低血糖较低，第52周时，IDeg - flex与IGlar组夜间确诊低血糖较低（P = 0.026）。IDeg可以在一天中的任何时间给药，注射时间不同，不会影响血糖控制或安全性，而不是每天同一时间的IDeg或IGlar。这可能通过允许根据个人需要调整注射时间来改善基础胰岛素依从性。
This study investigated the efficacy and safety of insulin degludec (IDeg) once daily (OD), varying injection timing day to day in subjects with type 1 diabetes. This 26-week, open-label, treat-to-target, noninferiority trial compared IDeg forced flexible (Forced-Flex) OD (given in a fixed schedule with a minimum 8 and maximum 40 hours between doses) with IDeg or insulin glargine (IGlar) given at the same time daily OD. In the 26-week extension, all IDeg subjects were transferred to a free-flexible (Free-Flex) regimen, which allowed any-time-of-day dosing, and compared with subjects continued on IGlar. After 26 treatment weeks, mean glycosylated hemoglobin was reduced with IDeg Forced- Flex (−0.40%), IDeg (−0.41%), and IGlar (−0.58%). IDeg Forced-Flex noninferiority was achieved. Fasting plasma glucose reductions were similar with IDeg Forced-Flex and IGlar but greater with IDeg (−2.54 mmol/L) than IDeg Forced-Flex (−1.28 mmol/L) (P = .021). At week 52, IDeg Free-Flex subjects had similar glycosylated hemoglobin but greater fasting plasma glucose reductions than IGlar subjects (−1.07 mmol/L) (P = .005). Confirmed hypoglycemia rates (plasma glucose <3.1 mmol/L or severe hypoglycemia) were similar at weeks 26 and 52. Nocturnal confirmed hypoglycemia was lower with IDeg Forced-Flex vs IDeg (37%; P = .003) and IGlar (40%; P = .001) at week 26 and 25% lower with IDeg Free-Flex vs IGlar (P = .026) at week 52. IDeg can be administered OD at any time of day, with injection timing varied without compromising glycemic control or safety vs same-time-daily IDeg or IGlar. This may improve basal insulin adherence by allowing injection-time adjustment according to individual needs.
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与中性鱼精蛋白哈格多恩胰岛素相比，地特胰岛素在 1 型糖尿病患者中的长期疗效和安全性采用门冬胰岛素治疗目标基础推注方案：一项为期 2 年的随机对照试验。
DOI：
10.1111/j.1464-5491.2007.02407.x
发表时间：
2008-04
期刊：
Diabetic medicine : a journal of the British Diabetic Association
影响因子：
--
作者：
Bartley PC;Bogoev M;Larsen J;Philotheou A
通讯作者：
Philotheou A
糖尿病的医疗标准 - 2010年。
影响因子：
16.2
作者：
American Diabetes Association
通讯作者：
American Diabetes Association
影响因子：
2.2
作者：
Mire-Sluis, AR;Barrett, YC;Zuckerman, LA
通讯作者：
Zuckerman, LA
DOI：
10.1111/j.1464-5491.2012.03605.x
发表时间：
2012-05
期刊：
Diabetic medicine : a journal of the British Diabetic Association
影响因子：
--
作者：
Peyrot M;Barnett AH;Meneghini LF;Schumm-Draeger PM
通讯作者：
Schumm-Draeger PM
影响因子：
16.2
作者：
Peyrot M;Rubin RR;Kruger DF;Travis LB
通讯作者：
Travis LB