A Prospective, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).
详细描述
The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 and ≤75 years with type 1 diabetes;
- •Diagnosed as T1DM ≥ 12 months before enrollment in the study;
- •HbA1c ≥ 7.0 to ≤10.0%;
- •Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;
- •BMI ≤ 35kg / m2.
排除标准
- •Patients with any of the following conditions will be excluded:
- •Pregnant or lactating women
- •Severe hypoglycemia within one month;
- •Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
- •Receipt of Sulfonylureas, Meglitinides derivatives, Thiazolidinediones, Dpp-4 inhibitors or GLP-1 agonists within 3 months prior to informed consent;
- •Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
- •Severe mental instability, or alcohol abuse, or drug abuse
- •Cancer within 5 years prior to informed consent
- •Pancreatitis of severe infectious diseases within 1 months prior to informed consent
- •Known hypersensitivity or allergy to the insulin
- •Renal impairment (CKD-EPI eGFR<60ml/min)
- •Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
- •Participation in another trial within 2 months prior to informed consent
- •Patients that investigators believe may fail to complete the study
研究组 & 干预措施
IDegAsp group
IDegAsp twice daily
干预措施: insulin degludec/insulin aspart (IDegAsp) (Drug)
basal insulin plus pre-prandial insulin group
basal insulin once or twice daily plus pre-prandial insulin
干预措施: basal insulin plus pre-prandial insulin (Drug)
结局指标
主要结局
HbA1c
时间窗: 16 weeks
the change from baseline in HbA1c after 16 weeks of treatment in all patients
次要结局
- Time In Range (TIR)(16 weeks)
- Time to occurrence of treat to target(16 weeks)
- Occurrence of a treat to target response and without any hypoglycemic episodes(16 weeks)
- EQ-5D Health Questionnaire(16 weeks)
- Short Form 36 (SF-36)(16 weeks)
- Insulin dose(16 weeks)