NCT03191396已完成3 期
Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
排除标准
- •Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
研究组 & 干预措施
Semaglutide
Experimental
Half the study participants are randomised to receive semaglutide
干预措施: Semaglutide (Drug)
Liraglutide
Active Comparator
Half the study participants are randomised to receive liraglutide
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0, week 30
Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
次要结局
- Change in Fasting Plasma Glucose (FPG)(Week 0, week 30)
- Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol(Week 0, week 30)
- Change in Body Weight (%)(Week 0, week 30)
- Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target(After 30 weeks of treatment)
- Change in Fasting Blood Lipids: Total Cholesterol(Week 0, week 30)
- Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol(Week 0, week 30)
- Change in Fasting Blood Lipids: Triglycerides(Week 0, week 30)
- Change in Systolic Blood Pressure(Week 0, week 30)
- Change in Body Weight (kg)(Week 0, week 30)
- Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile(Week 0, week 30)
- Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)(Week 0, week 30)
- Change in Body Mass Index (BMI)(Week 0, week 30)
- Change in Waist Circumference(Week 0, week 30)
- Change in Diastolic Blood Pressure(Week 0, week 30)
- Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%(After 30 weeks of treatment)
- Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%(After 30 weeks of treatment)
- Number of Treatment-emergent Adverse Events (TEAE)(Week 0 to week 35)
- Subjects Who Achieve Weight Loss Above or Equal to 3%(After 30 weeks of treatment)
- Subjects Who Achieve Weight Loss Above or Equal to 10%(After 30 weeks of treatment)
- Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target(After 30 weeks of treatment)
- Subjects Who Achieve Weight Loss Above or Equal to 5%(After 30 weeks of treatment)
- Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%(After 30 weeks of treatment)
- Change in Biochemistry - Calcium, Pottassium and Sodium(Week 0, week 30)
- Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain(After 30 weeks of treatment)
- Subjects Who Achieve HbA1c Reduction Above or Equal to 1%(After 30 weeks of treatment)
- Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains(Week 0, week 30)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately(Week 0, week 30)
- Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes(Week 0 to week 35)
- Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes(Week 0 to week 35)
- Change in Haematology - Haematocrit(Week 0, week 30)
- Change in Haematology - Thrombocytes and Leukocytes(Week 0, week 30)
- Change in Haematology - Erythrocytes(Week 0, week 30)
- Change in Biochemistry - Creatinine and Bilirubin(Week 0, week 30)
- Change in Calcitonin(Week 0, week 30)
- Change in Haematology - Haemoglobin(Week 0, week 30)
- Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.(Week 0, week 30)
- Change in Biochemistry - Amylase and Lipase(Week 0, week 30)
- Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).(Week 0, week 30)
- Change in Biochemistry - Albumin(Week 0, week 30)
- Change in Pulse Rate(Week 0, week 30)
研究者
研究点 (1)
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