EUCTR2020-005281-34-HR进行中（未招募）1 期
A 52 week study comparing the efficacy and safety of once weekly IcoSema and once weekly insulin icodec, both treatment arms with or without oral anti diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin. COMBINE 1 - COMBINE 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,290
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 and age above or equal to 18 years at the time of signing informed consent.
- •- Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
- •- Glycated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- •- Treated with once daily or twice daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses above or equal to 90 days before screening:
- •Sulfonylureas *
- •Meglitinides (glinides) *
- •DPP 4 inhibitors *
- •Sodium glucose co transporter 2 inhibitors
- •Alpha glucosidase inhibitors
- •Thiazolidinediones
- •Marketed oral combination products only including the products listed above.
- •- Body mass index (BMI) less than or equal to 40.0 kg/m^2.
- •* Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation.
- •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 1160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- •- Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids).
- •- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •- Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening.
- •- Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
- •- Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
- •- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- •- Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.
研究者
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