EUCTR2018-003407-18-CZ进行中（未招募）1 期
A trial comparing NNC0148-0287 C (insulin 287) versus insulin glargine U100, both incombination with metformin, with or without DPP4 inhibitors and with or without SGLT2inhibitors, in basal insulin treated subjects with type 2 diabetes mellitus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- •2. Diagnosed with type 2 diabetes mellitus equal to or more than 180 days prior to the day of screening.
- •3. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
- •4. Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) equal to or more than 90 days prior to the day of screening.
- •5. Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
- •a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose (as documented in subject’s medical records)
- •b. Free or fixed combination therapy: Metformin as outlined above with or without DPP4i with or without SGLT2i is allowed:
- •b. 1: DPP4i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)
- •b.2: SGLT2i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose )
- •6. Body mass index (BMI) equal to or below 40.0 kg/m^2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1. Known or suspected hypersensitivity to trial product(s) or related products.
- •2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
- •3. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
- •4. Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
- •5. Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
- •6. Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question 8.
- •7. Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
- •8. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
研究者
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