NCT07018453进行中（未招募）2 期
A Randomized, Open-label, Treat-to-target, Parallel-Controlled Phase II Clinical Study Investigating the Efficacy and Safety of SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Change in glycosylated hemoglobin (HbA1c) from baseline.
研究概览
简要总结
The purpose of this study is to evaluate the glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 - 65 years old at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening.
- •Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening.
- •6.5% ≤ HbA1c ≤ 10.0% at screening.
排除标准
- •Uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
- •Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
- •Known or suspected allergy or intolerance to the test drug or excipient.
- •There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- •There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
- •There is hyperthyroidism or hypothyroidism requiring treatment.
- •Malignancy within 5 years prior to screening or high risk of recurrence.
- •Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
- •Participated in clinical trials of any drug or medical device within 3 months prior to screening.
研究组 & 干预措施
Insulin Degludec Group
Active Comparator
干预措施: Insulin Degludec (Drug)
SHR-3167 Group A
Experimental
干预措施: SHR-3167 (Drug)
SHR-3167 Group B
Experimental
干预措施: SHR-3167 (Drug)
结局指标
主要结局
Change in glycosylated hemoglobin (HbA1c) from baseline.
时间窗: 16 weeks.
次要结局
- Change in self-measured (capillary) blood glucose (SMBG) from baseline.(16 weeks.)
- Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline.(16 weeks.)
- Change in fasting plasma glucose (FPG) from baseline.(16 weeks.)
研究者
研究点 (2)
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