Harreiter Jürgen, Kosi-Trebotic Lana, Lukas Albert, Wolf Peter, Winhofer Yvonne, Luger Anton, Kautzky-Willer Alexandra, Krebs Michael R
Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Währingergürtel 18-20, 1090, Vienna, Austria.
Diabetes Ther. 2017 Jun;8(3):683-692. doi: 10.1007/s13300-017-0249-4. Epub 2017 Mar 29.
To prove the feasibility and safety of a conversion to once-daily injected GLP1 agonist (lixisenatide) and long-acting basal insulin analogue (glargine) in patients with T2DM and poorly controlled glycemia previously treated with multiple injections of premixed insulins (iPremix) in an outpatient setting.
Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue glargine (iGlar) for a 12-week period. Efficacy was defined as A1c reduction of at least 0.4% and weight loss of 0.5 kg or higher.
Five of nine patients achieved A1c reductions of 0.4% (4 mmol/mol) or higher and six of nine patients a weight loss of 0.5 kg or higher. A mean A1C reduction of 0.5% ± 0.5% (6 mmol/mol) and mean weight loss of -1.4 ± 3.6 kg were observed in all patients. Total daily insulin dose after 12 weeks declined from 56 ± 26 IU with iPremix formulations to 47 ± 17 IU in patients taking combined iGlar and Lixi. Corrections with fast acting insulin glulisine (iGlu) were necessary in two patients on a regular basis and in four patients on an irregular basis (2.3 IU mean total daily dose). Two patients did not need additional iGlu. Postprandial glucose profiles were lower in the combined group compared with iPremix throughout the day, which resolved in the afternoon. No metabolic derangements occurred. Mild hypoglycemia and gastrointestinal symptoms were the most often reported adverse events affecting three patients.
The conversion to once-daily injected GLP1 agonist Lixi and basal iGlar could safely be performed in an outpatient setting and was associated with better postprandial glycemic control throughout the day, except dinner, compared to iPremix.
EU clinical trials register EudraCT number 2013-005334-37 and ClinicalTrials.gov NCT02168491.
Sponsored by the Medical University of Vienna and in part supported by Sanofi-Aventis.
为证明在门诊环境中，将预混胰岛素多次注射治疗的2型糖尿病（T2DM）且血糖控制不佳的患者转换为每日一次注射胰高血糖素样肽-1（GLP-1）受体激动剂（利司那肽）和长效基础胰岛素类似物（甘精胰岛素）的可行性和安全性。
9例目前接受预混胰岛素制剂且血糖控制不佳的T2DM患者转换为每日一次注射利司那肽（Lixi）和基础胰岛素类似物甘精胰岛素（iGlar），为期12周。疗效定义为糖化血红蛋白（A1c）降低至少0.4%且体重减轻0.5 kg或更多。
9例患者中有5例A1c降低0.4%（4 mmol/mol）或更多，9例患者中有6例体重减轻0.5 kg或更多。所有患者的平均A1c降低0.5%±0.5%（6 mmol/mol），平均体重减轻-1.4±3.6 kg。12周后，每日胰岛素总剂量从预混胰岛素制剂的56±26 IU降至联合使用甘精胰岛素和利司那肽患者的47±17 IU。2例患者定期需要速效胰岛素赖谷胰岛素（iGlu）纠正，4例患者不定期需要（平均每日总剂量2.3 IU）。2例患者不需要额外的iGlu。联合治疗组全天餐后血糖曲线低于预混胰岛素组，下午恢复正常。未发生代谢紊乱。轻度低血糖和胃肠道症状是最常报告的不良事件，影响3例患者。
与预混胰岛素相比，在门诊环境中安全地将治疗转换为每日一次注射GLP-1受体激动剂利司那肽和基础甘精胰岛素，并与全天（晚餐除外）更好的餐后血糖控制相关。
欧盟临床试验注册中心EudraCT编号2013-005334-37以及ClinicalTrials.gov编号NCT02168491。
由维也纳医科大学赞助，部分由赛诺菲-安万特支持。
