One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.
One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.
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DOI：
10.1111/dom.12498
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发表时间：
2015-10
期刊：
影响因子：
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通讯作者：
Buse JB
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文献类型：
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作者：
Gough SC;Bode BW;Woo VC;Rodbard HW;Linjawi S;Zacho M;Reiter PD;Buse JB
在一项为期26周的扩展研究中，在2型糖尿病患者中，与单独使用胰岛素或利拉鲁肽相比，degludec胰岛素和利拉鲁肽固定联合使用（IDegLira）的持续有效性和安全性得到了证实。胰岛素naïve成人2型糖尿病患者随机分配到每日一次的IDegLira，胰岛素degludec或利拉鲁肽，除了二甲双胍±吡格列酮，继续他们分配的治疗，在这个预先计划的26周延长DUAL I试验中。共有78.8%的患者（1311/1663）继续进入延长期。52周时，IDegLira组平均糖化血红蛋白（HbA1c）浓度较基线降低1.84% (20.2 mmol/mol)，胰岛素-葡糖苷组降低1.40% (15.3 mmol/mol)，利拉鲁肽组降低1.21% （13.2 mmol/mol）。在接受IDegLira治疗的患者中，78%的患者HbA1c <7% (53 mmol/mol)，而接受degludec胰岛素治疗的患者中这一比例为63%，接受利拉鲁肽治疗的患者中这一比例为57%。试验结束时，IDegLira （5.7 mmol/l）和degludec胰岛素（6.0 mmol/l）的平均空腹血浆葡萄糖浓度相似，但利拉鲁肽更高（7.3 mmol/l）。在52周时，IDegLira的每日胰岛素剂量（39个单位）比degludec的每日胰岛素剂量（62个单位）低37%。与degludec胰岛素相比，IDegLira与体重显著降低（估计治疗差异为- 2.80 kg, p < 0.0001）和低血糖率降低37%相关。总体而言，所有治疗均具有良好的耐受性，IDegLira未观察到新的不良事件或耐受性问题。这些12个月的数据来自于DUAL I试验的26周延长，证实了最初的26周主期结果和IDegLira在降糖功效、安全性和耐受性方面与其成分相比的可持续性益处。
To confirm, in a 26‐week extension study, the sustained efficacy and safety of a fixed combination of insulin degludec and liraglutide (IDegLira) compared with either insulin degludec or liraglutide alone, in patients with type 2 diabetes. Insulin‐naïve adults with type 2 diabetes randomized to once‐daily IDegLira, insulin degludec or liraglutide, in addition to metformin ± pioglitazone, continued their allocated treatment in this preplanned 26‐week extension of the DUAL I trial. A total of 78.8% of patients (1311/1663) continued into the extension phase. The mean glycated haemoglobin (HbA1c) concentration at 52 weeks was reduced from baseline by 1.84% (20.2 mmol/mol) for the IDegLira group, 1.40% (15.3 mmol/mol) for the insulin degludec group and 1.21% (13.2 mmol/mol) for the liraglutide group. Of the patients on IDegLira, 78% achieved an HbA1c of <7% (53 mmol/mol) versus 63% of the patients on insulin degludec and 57% of those on liraglutide. The mean fasting plasma glucose concentration at the end of the trial was similar for IDegLira (5.7 mmol/l) and insulin degludec (6.0 mmol/l), but higher for liraglutide (7.3 mmol/l). At 52 weeks, the daily insulin dose was 37% lower with IDegLira (39 units) than with insulin degludec (62 units). IDegLira was associated with a significantly greater decrease in body weight (estimated treatment difference, −2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec. Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira. These 12‐month data, derived from a 26‐week extension of the DUAL I trial, confirm the initial 26‐week main phase results and the sustainability of the benefits of IDegLira compared with its components in glycaemic efficacy, safety and tolerability.