NCT05802862已完成3 期
A Multi-center, Randomized, Open, Phase III Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared Efficacy and Safety With Insulin Degludec/Insulin Aspart(Ryzodeg) in Chinese Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).
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
- •Informed consent obtained before any trial-related activities.
- •Male or female, age at least 18 year-old and no more than 75 year-old at the time of signing informed consent.
- •Type 2 diabetes mellitus (T2D).
- •Body mass index (BMI) higher than 18.0, but below or equal to 35.0 kg/m^
- •Current treatment for at least 3 months prior to screening with basal insulin/premixed insulin once a day or twice a day with/without oral anti-diabetic drugs (OADs): metformin, alpha-glucosidase inhibitors, dimethylphenylpenicillin dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-dependent glucose transporter 2 (SGLT-2) inhibitors . For above or equal to 3 months prior to screening subjects should be on a stable dose.
- •HbA1c from 7-11.0% both inclusive at screening confirmed by central laboratory analysis.
排除标准
- •Have a diagnosis of type 1 diabetes (T1D), or specific type of diabetes other than T2D, for example, injured pancreas, diseases of acromegaly-induced diabetes.
- •Have a history of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
- •Have had severe hypoglycemia episodes within 6 months prior to screening.
研究组 & 干预措施
22011
Experimental
干预措施: Insulin Degludec and Insulin Aspart (Drug)
Ryzodeg
Active Comparator
干预措施: Insulin Degludec and Insulin Aspart (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline to Week 24
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
次要结局
- Change From Baseline in Body weight(Baseline to Week24)
- Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%(Baseline to Week24)
- Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes(Baseline to Week24)
- Change From Baseline in Fasting Plasma Glucose(FPG) in Week24(Baseline to Week24)
- Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24(Baseline to Week24)
- Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)(from baseline to Week25)
- Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12(Baseline to Week12)
- Change From Baseline in Fasting Plasma Glucose(FPG)(Baseline to Week12)
- Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values(Baseline to Week12)
研究者
研究点 (1)
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