JPRN-jRCTs051180138已完成3 期
Effects of Insulin Degludec and Insulin Glargine U300 on glucose variability in Individuals with Type 1 Diabetes: a Multicenter, Randomized, Crossover Study - Kobe Best Basal Insulin Study 2
Sakaguchi Kazuhiko0 个研究点目标入组 46 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) individuals with type 1 diabetes
- •(2) aged at least 20 years
- •(3) serum C-peptide immunoreactivity is <0.2 ng/mL (as confirmed at least twice)
- •(4) treatment for at least 1 year with basal-bolus insulin injections, with the basal insulin and a rapid-acting insulin analog or regular insulin as the bolus insulin
- •(5) the ability to perform self-monitoring of blood glucose (SMBG)
- •(6) the ability to perform CGM
- •(7) individuals who have get a concent
排除标准
- •(1) a glycated hemoglobin (HbA1c) level of 9.0% or higher
- •(2) rejection of SMBG or FGM
- •(3) use of medications that affect glucose metabolism (such as beta-blockers, corticosteroids, and monoamine oxidase inhibitors)
- •(4) a history of myocardial infarction, angina, coronary bypass surgery, or heart failure within the previous 6 months
- •(5) severe hypertension (systolic blood pressure of at least 180 mmHg or diastolic blood pressure of at least 100 mmHg)
- •(6) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase levels of at least 2.5 times the upper limit of normal)
- •(7) severe renal impairment (serum creatinine concentration of at least 2.0 mg/dL)
- •(8) frequently recurring severe hypoglycemia or hospitalization because of serious hypoglycemia or diabetic ketoacidosis within the previous year
- •(9) proliferative diabetic retinopathy with a high risk of hemorrhage
- •(10) existing or possible pregnancy or breastfeeding or no use of an adequate contraceptive method
- •(11) a diagnosis of cancer
- •(12) a complicating psychiatric disorder
- •(13) alcoholism or other drug addiction
- •(14) declaration by an investigator that the individual is otherwise inappropriate for the study
研究者
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