Vrebalov Cindro Pavle, Krnić Mladen, Modun Darko, Vuković Jonatan, Tičinović Kurir Tina, Kardum Goran, Rušić Doris, Šešelja Perišin Ana, Bukić Josipa
Department of Gastroenterology, University Hospital Split, Split, Croatia.
Department of Endocrinology, University Hospital Split, Split, Croatia.
JMIR Form Res. 2022 Jul 8;6(7):e35655. doi: 10.2196/35655.
There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300). There is little data and head-to-head comparison of IDeg-100 and IGlar-300 regarding their simultaneous impact on glycemic variability and oxidative stress in patients with type 2 diabetes mellitus (T2DM).
In our randomized, open-label, crossover study, we compared the impact of IDeg-100 and IGlar-300 on glycemic variability and oxidative stress in insulin-naive patients with T2DM.
We recruited a total of 25 adult patients with T2DM (7 females) whose diabetes was uncontrolled (HbA ≥7.5%) on two or more oral glucose-lowering drugs; a total of 22 completed the study. Mean age was 57.3 (SD 6.99) years and duration of diabetes was 9.94 (SD 5.01) years. After the washout period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was administered for 12 weeks and then switched. At the beginning and end of each phase, biochemical and oxidative stress parameters were analyzed. On 3 consecutive days prior to each control point, patients performed a 7-point self-monitoring of blood glucose profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (determination of reactive oxygen metabolites test) in serum.
IGlar-300 reduced mean glucose by 0.02-0.13 mmol/L, and IDeg-100 reduced glucose by 0.10-0.16 mmol/L, with no significant difference. The reduction of the coefficient of glucose variation also did not show a statistically significant difference. IGlar-300 increased thiols by 0.08 µmol/L and IDeg-100 increased thiols by 0.15 µmol/L, with no significant difference (P=.07) between them. IGlar-300 reduced hydroperoxides by 0.040 CARR U and IDeg-100 increased hydroperoxides by 0.034 CARR U, but the difference was not significant (P=.12).
The results of our study do not show a significant difference regarding glycemic variability between patients receiving either insulin IDeg-100 or IGlar-300, although IGlar-300 showed greater dispersion of data. No significant difference in oxidative stress was observed. In a larger study, doses of insulins should be higher to achieve significant impact on glycemic parameters and consequently on glycemic variability and oxidative stress.
ClinicalTrials.gov, NCT04692415; https://clinicaltrials.gov/ct2/show/NCT04692415.
关于德谷胰岛素（IDeg-100）和甘精胰岛素U300（IGlar-300）之间可能存在的差异，目前仍在讨论中。关于IDeg-100和IGlar-300对2型糖尿病（T2DM）患者血糖变异性和氧化应激的同时影响，相关数据较少且缺乏直接比较。
在我们的随机、开放标签、交叉研究中，我们比较了IDeg-100和IGlar-300对初治T2DM患者血糖变异性和氧化应激的影响。
我们共招募了25例成年T2DM患者（7例女性），他们在使用两种或更多种口服降糖药物治疗时糖尿病控制不佳（糖化血红蛋白≥7.5%）；共有22例完成了研究。平均年龄为57.3（标准差6.99）岁，糖尿病病程为9.94（标准差5.01）年。在洗脱期后，他们被交替随机分组，首先接受IDeg-100或IGlar-300联合二甲双胍治疗。每种胰岛素给药12周，然后换药。在每个阶段开始和结束时，分析生化和氧化应激参数。在每个控制点前连续3天，患者进行7点血糖自我监测。通过测量血清中的巯基和氢过氧化物（活性氧代谢产物检测）评估氧化应激。
IGlar-300使平均血糖降低0.02 - 0.13 mmol/L，IDeg-100使血糖降低0.10 - 0.16 mmol/L，差异无统计学意义。血糖变异系数的降低也未显示出统计学显著差异。IGlar-300使巯基增加0.08 μmol/L，IDeg-100使巯基增加0.15 μmol/L，两者之间差异无统计学意义（P = 0.07）。IGlar-300使氢过氧化物降低0.040 CARR U，IDeg-100使氢过氧化物增加0.034 CARR U，但差异不显著（P = 0.12）。
我们的研究结果表明，接受IDeg-100或IGlar-300胰岛素治疗的患者在血糖变异性方面没有显著差异，尽管IGlar-300的数据离散度更大。在氧化应激方面未观察到显著差异。在更大规模的研究中，胰岛素剂量应更高，以对血糖参数产生显著影响，进而对血糖变异性和氧化应激产生显著影响。
ClinicalTrials.gov，NCT04692415；https://clinicaltrials.gov/ct2/show/NCT04692415 。
