CTRI/2024/02/062375已完成3 期
A 40-week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in participants with type 2 diabetes inadequately controlled on oral anti-diabetic drugs.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 12
- 主要终点
- Change in HbA1c %
研究概览
简要总结
This study is designed to investigate the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in type 2 diabetes (T2D) participants inadequately controlled on oral anti-diabetic drugs (OADs).IcoSema could be a more convenient injectable option compared to daily basal insulin in people with T2D who are inadequately controlled on OADs. Once weekly IcoSema has been developed with the intent to provide a more convenient and simple treatment regimen with significantly fewer injections, all in one pen, and thereby improve the treatment adherence. Further, IcoSema is expected to minimise the risk of hypoglycaemia and to provide a weight benefit compared to daily basal insulin treatment. As per latest ADA/EASD recommendations, a fixed ratio combination of insulin and GLP-1 RA can be considered for people with T2D who are inadequately controlled on OADs especially in people with T2D who are in need of higher efficacy. Overall, the results of the present study will be important for evaluating the efficacy and safety of IcoSema in participants with T2D inadequately controlled on OADs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female and age above or equal to 18 years at the time of signing the informed consent.
- •Diagnosed with T2D greater than or equal to 180 days before screening.
- •HbA1c greater than or equal to 8.0% (greater than or equal to 64.0 mmol/mol) as assessed by central laboratory on the day of screening.
- •Insulin naïve.
- •Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes.
- •Currently treated with 1-3 OADs with stable daily doses greater than or equal to 90 days before screening comprising any of the following anti-diabetic drug(s) at effective or maximum tolerated dose: Metformin, 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/m2.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using 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).
- •Any episodesa of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •Presence or history of pancreatitis (acute or chronic) within 180 days before screening.b
- •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 aas declared by the participant or in the medical records, bFor Turkey, stricter exclusion criteria applies “Presence or history of pancreatitis (acute or chronic)†For Italy, an additional exclusion criteria “known severe diabetic autonomic neuropathy as judged by the investigator†is applicable.
- •Data monitoring committee: No.
结局指标
主要结局
Change in HbA1c %
时间窗: from baseline week 0 (V2) to week 40 (V42).
次要结局
- Change in body weight Kg(From baseline week 0 (V2) to week 40 (V42)
- Time in range 3.9-10.0 mmol/L (70-180 mg/dL) Using study provisioned continuous glucose monitoring (CGM) system, Dexcom G6(From week 36 (V38) to week 40 (V42))
- Time spent 3.0 mmol/L (54 mg/dL) aUsing study provisioned continuous glucose monitoring (CGM) system, Dexcom G6(From week 36 (V38) to week 40 (V42))
- Time spent 10.0 mmol/L (180 mg/dL) Using study provisioned continuous glucose monitoring (CGM) system, Dexcom G6(From week 36 (V38) to week 40 (V42))
- Weekly basal insulin dose(From week 38 (V40) to week 40 (V42))
- Change in fasting plasma glucose (FPG) mmol/L(From baseline week 0 (V2) to week 40 (V42))
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction- Score 0-36 bHigher the score the greater the satisfaction with medication(From baseline week 0 (V2) to week 40 (V42))
- Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)(From baseline week 0 (V2) to week 45 (V44))
- Number of clinically significant hypoglycaemic episodes (level 2) (3.0 mmol/L (54 mg/dL), confirmed by BG meter)(From baseline week 0 (V2) to week 45 (V44))
- Number of severe hypoglycaemic episodes (level 3)(From baseline week 0 (V2) to week 45 (V44))
研究者
研究点 (12)
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