NCT04663282已完成2 期
Evaluation of the Efficacy and Safety of INS068 Injection and Insulin Degludec Subcutaneous Injection Once Daily in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With One or Two Oral Antidiabetics (A Randomized, Open-Label, Two-Arm, Treat-to-Target, Parallel Controlled Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 35
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of IND068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with one or two oral antidiabetics compared to insulin degludec QD for 16 weeks.
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. (Trial-related activities are any procedure that will not have been performed during normal management of the subject.)
- •Age is 18-75 years
- •Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable locally) for at least 3 months
- •Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily dose of ≥ 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD other than metformin should be minimum half of the daily maximal dose according to local labelling or maximum tolerated dose.
- •Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of ≤14 days) and insulin treatment for gestational diabetes are allowed.
- •HbA1c 7.0-10.0 % (53-85 mmol/mol) (both inclusive)
- •BMI 19-40 kg/m2 (both inclusive)
排除标准
- •Known or suspected allergy or intolerance to the active substance or to any of the excipients of the investigational medical products
- •Severe hypoglycemia during the previous 6 months.
- •Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months.
- •Cardiovascular disease within the last 12 months, defined as: stroke, decompensated heart failure (New York Heart Association [NYHA] class III or IV), myocardial infarction, or hospitalization for unstable angina pectoris or transient ischemic attack.
- •Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer, polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or relapse of cancer.
- •Any antidiabetic medication other than permitted in the inclusion criteria or any weight-loss drug within the last 8 weeks..
- •Systemic or intra-articular corticosteroids treatment within the last 3 months.
研究组 & 干预措施
INS068
Experimental
Intervention: Drug: INS068 injection
干预措施: INS068 injection (Drug)
IDeg
Active Comparator
Intervention: Drug: insulin Degludec
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0 to Week 16
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
次要结局
- 9-point SMPG profiles(Week 0 to Week 16)
- Changes in Body Mass Index(Week 0 to Week 16)
- Proportion of subjects reaching HbA1c targets(Week 0 to Week 16)
- Frequency and severity of adverse events(Week 0 to Week 16 + 14 days follow-up)
- Anti-drug Antibodies: Anti-INS068 Antibodies(Week 0 to Week 16+14 days follow-up)
- Changes in Body Weight(Week 0 to Week 16)
- Change in FPG(Week 0 to Week 16)
- Titration target(Week 0 to Week 16)
- Pre-breakfast SMPG(Week 0 to Week 16)
- Change in Health Related Quality of Life Questionnaire (SF -36)(Week 0 to Week 16)
- Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication(Week 0 to Week 16)
- Numbers of injection site reactions(Week 0 to Week 16)
- Serum INS068 concentration(Week 0 to Week 16)
研究者
研究点 (35)
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