NL-OMON54981已完成3 期
A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen. - ONWARDS 4
ovo Nordisk0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female aged above or equal to 18 years at the time of signing
- •informed consent.
- •- Diagnosed with T2D * 180 days prior to the day of screening.
- •- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening
- •confirmed by central laboratory analysis.
- •- Treated with once daily basal insulin (neutral protamine hagedorn insulin,
- •insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin
- •glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog
- •(insulin aspart, faster acting insulin aspart, insulin lispro, faster acting
- •insulin lispro, insulin glulisine) * 90 days prior to the day of screening with
- •or without any of the following anti-diabetic drugs/regimens with stable doses
- •* 90 days prior to screening:
- •* Metformin
- •* Sulfonylureas
- •* Meglitinides (glinides)
- •* DPP-4 inhibitors
- •* SGLT2 inhibitors
- •* Thiazolidinediones
- •* Alpha-glucosidase inhibitors
- •* Oral combination products (for the allowed individual oral anti-diabetic
- •* Oral or injectable GLP-1 RAs
- •- Body mass index (BMI) * 40.0 kg/m2
排除标准
- •- Any episodes (as declared by the subject or in the medical records) of
- •diabetic ketoacidosis within 90 days prior to the day of screening.
- •- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris
- •or transient ischaemic attack within 180 days prior to the day of screening.
- •- Chronic heart failure classified as being in New York Heart Association Class
- •IV at screening.
- •- Anticipated initiation or change in concomitant medications (for more than 14
- •consecutive days) known to affect weight or glucose metabolism (e.g. treatment
- •with orlistat, thyroid hormones, or corticosteroids).
- •- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Verified by a fundus examination performed within the past 90 days prior to
- •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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