2024-510612-75-00已完成3 期
Efficacy and safety of once-weekly semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine vs titrated insuline glargine in participants with type 2 diabetes and overweight
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 59
- 主要终点
- Change in HbA1c from baseline (week 0) to end of treatment (week 40)
研究概览
简要总结
To confirm that efficacy as measured by change from baseline to week 40 in HbA1c (%-point) of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine U100 is not unacceptably worse (i.e., non-inferior) to that of titrated insulin glargine U100 on change from baseline to week 40 in HbA1c (%-point) in participants with T2D and overweight treated with a once daily basal insulin up to 40 U/day. Non-inferiority is assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2D mellitus ≥180 days before screening.
- •HbA1c of 7-10% (53−86 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- •Body mass index (BMI) ≥25 kg/m2 on the day of screening.
- •Stable daily dose(s) ≥90 days before screening of any of the following anti-diabetic drugs or combination regimens: -Any metformin formulations ≥1500 mg or maximum tolerated or effective dose. -Any metformin combination formulation ≥1500 mg or maximum tolerated or effective dose. The treatment can be with or without SGLT-2 inhibitors.
- •Treated with a once daily basal insulin (e.g. insulin glargine U100 or U300, NPH insulin, insulin detemir, insulin degludec) ≤40 U/day for ≥90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.
排除标准
- •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.
- •Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide <0.26 nmol/L or 260 pmol/L (0.78 ng/mL) or antibodies to glutamic acid decarboxylase (anti-GAD) >5 units/mL, as measured by the central laboratory at screening.
- •Presence or historya of pancreatitis (acute or chronic).
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of <30 mL/min/1.73 m2 at screening as defined by KDIGO 2012 classification.
- •Any episodes of diabetic ketoacidosis within 90 days before screening.
- •Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8.
结局指标
主要结局
Change in HbA1c from baseline (week 0) to end of treatment (week 40)
Change in HbA1c from baseline (week 0) to end of treatment (week 40)
次要结局
- Change in body weight from baseline (week 0) to end of treatment (week 40)
- Relative change in daily insulin dose from baseline (week 0) to end of treatment (week 40)
- Change in HbA1c From baseline (week 0) to end of treatment (week 40)
- Score of Diabetes Treatment Satisfaction Questionnaire – change version (DTSQc) At end of treatment (week 40)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (59)
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