A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insulin.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 580
- 试验地点
- 12
- 主要终点
- To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with
研究概览
简要总结
This is a 26-week randomised, open label, active-controlled, parallel-group, multicentre, multinational, treat-to-target trial with two treatment arms investigating the effect on glycaemic control and safety of treatment with once weekly insulin icodec compared to once daily insulin glargine, both in combination with insulin aspart with or without non-insulin anti-diabetic drugs, in subjects with T2D.The trial duration is approximately 33 weeks, consisting of a 2-week screening period, followed by a 26-week randomised treatment period and a 5-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities.
- •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Male or female.
- •Age 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 drugs) • Oral or injectable GLP-1 RAs
- •Body mass index (BMI) ≤ 40.0 kg/m2.
排除标准
- •Subjects are excluded from the trial if any of the following criteria apply:
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Previous participation in this trial.
- •Participation is defined as signed informed consent.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screeninga.
结局指标
主要结局
To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with
时间窗: Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus
时间窗: Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
VV-
时间窗: Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
regimen. This includes comparing the difference in change from baseline in HbA1c between insulin
时间窗: Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.
时间窗: Change in HbA1c, From baseline week 0 (V2) to week 26 (V28),unit %-point
次要结局
- Number of severe hypoglycaemic(episodes (level 3))
- Change in fasting plasma glucose((FPG))
- Time in target-range 3.9–10.0(mmol/L (70-180 mg/dL))
- Number of clinically significant(hypoglycaemic episodes (level 2))