Janić Miodrag, Janež Andrej, Šabović Mišo, El-Tanani Mohamed, Rangraze Imran, Rizzo Manfredi, Lunder Mojca
Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.
Faculty of Medicine, University of Ljubljana, 1000 Ljubljana, Slovenia.
J Clin Med. 2024 Nov 14;13(22):6860. doi: 10.3390/jcm13226860.
: People with type 1 diabetes have an unmet need for cardiovascular protection due to the lack of new recommended antidiabetic therapies with cardiovascular benefits. We examined whether the addition of an empagliflozin/metformin combination, and each drug alone, can complement insulin to improve glucometabolic parameters in overweight people with type 1 diabetes at high cardiovascular risk. : This pilot, single-center double-blind randomized controlled trial included 40 people with type 1 diabetes. In addition to insulin, they received empagliflozin (25 mg daily), metformin (2000 mg daily), an empagliflozin/metformin combination, or a placebo. The intervention period was 12 weeks. Glycemic parameters, insulin requirements, and blood and urine samples were analyzed. Indices for liver fibrosis were calculated. Due to potential safety concerns, participants regularly measured blood ketone values. : The empagliflozin/metformin combination decreased HbA1c (-0.6%, < 0.05) and weight (-6.1 kg, < 0.05). Empagliflozin decreased the urinary albumin-to-creatinine ratio (-31.4 ± 4.9%, = 0.002). The empagliflozin/metformin combination and empagliflozin decreased the estimated daily proteinuria (-34.6 ± 5.0%, = 0.006 and -35.9 ± 6.2%, = 0.03, respectively), the calculated FIB-4 (up to -17.8 ± 5.2%, = 0.04 and -10.7 ± 3.7%, = 0.02, respectively), and other liver fibrosis indices and uric acid values. No significant side effects occurred during the study. : The empagliflozin/metformin combination improved glycemic control, reduced weight and insulin requirements, and produced several additional beneficial metabolic effects in overweight people with type 1 diabetes with increased cardiovascular risk.
由于缺乏新的具有心血管益处的推荐抗糖尿病疗法，1型糖尿病患者对心血管保护的需求尚未得到满足。我们研究了恩格列净/二甲双胍联合用药以及每种药物单独使用时，能否在超重的、心血管风险高的1型糖尿病患者中辅助胰岛素治疗，以改善糖代谢参数。
这项单中心、双盲、随机对照试验纳入了40例1型糖尿病患者。除胰岛素外，他们分别接受恩格列净（每日25毫克）、二甲双胍（每日2000毫克）、恩格列净/二甲双胍联合用药或安慰剂治疗。干预期为12周。分析了血糖参数、胰岛素需求量以及血液和尿液样本。计算了肝纤维化指标。出于潜在安全性考虑，参与者定期测量血酮值。
恩格列净/二甲双胍联合用药降低了糖化血红蛋白（-0.6%，P<0.05）和体重（-6.1千克，P<0.05）。恩格列净降低了尿白蛋白肌酐比值（-31.4±4.9%，P = 0.002）。恩格列净/二甲双胍联合用药和恩格列净分别降低了估计每日蛋白尿（-34.6±5.0%，P = 0.006和-35.9±6.2%，P = 0.03）、计算得到的FIB-4（分别高达-17.8±5.2%，P = 0.04和-10.7±3.7%，P = 0.02）以及其他肝纤维化指标和尿酸值。研究期间未出现明显副作用。
恩格列净/二甲双胍联合用药改善了血糖控制，减轻了体重，降低了胰岛素需求量，并在心血管风险增加的超重1型糖尿病患者中产生了其他一些有益的代谢作用。
