NCT02648204已完成3 期
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin 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
- 1,201
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.
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 at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening
排除标准
- •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) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
研究组 & 干预措施
Semaglutide 0.5 mg/Week
Experimental
干预措施: semaglutide (Drug)
Semaglutide 1.0 mg/Week
Experimental
干预措施: semaglutide (Drug)
Dulaglutide 0.75 mg/Week
Active Comparator
干预措施: Dulaglutide (Drug)
Dulaglutide 1.5 mg/Week
Active Comparator
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0, week 40
Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
次要结局
- Change in Body Weight (kg)(Week 0, week 40)
- Change in Fasting Plasma Glucose(Week 0, week 40)
- Change in Systolic and Diastolic Blood Pressure(Week 0, week 40)
- Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire(Week 0, week 40)
- Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile(Week 0, week 40)
- HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target(After 40 weeks treatment)
- Change in Fasting Blood Lipids (Triglycerides)(Week 0, week 40)
- Change From Baseline 7-point Self-measured Plasma Glucose Increment(Week 0, week 40)
- Change in Fasting Blood Lipids (Total Cholesterol)(Week 0, week 40)
- Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)(Week 0, week 40)
- Change in Body Mass Index (BMI)(Week 0, week 40)
- Change in Waist Circumference(Week 0, week 40)
- Change in Short Form Health Survey (SF-36v2™)(Week 0, week 40)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target(After 40 weeks of treatment)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%(After 40 weeks treatment)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%(After 40 weeks treatment)
- Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)(Week 0, week 40)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain(After 40 weeks of treatment)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%(After 40 weeks of treatment)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%(After 40 weeks treatment)
- Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%(After 40 weeks treatment)
- Number of Treatment Emergent Adverse Events (TEAEs)(40 weeks + follow-up of 5 weeks)
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes(40 weeks + follow-up of 5 weeks)
- Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(40 weeks + follow-up of 5 weeks)
- Change in Amylase(Week 0, week 40)
- Change in Lipase(Week 0, week 40)
- Change in Pulse Rate(Week 0, week 40)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02305381Novo Nordisk A/S397
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT03086330Novo Nordisk A/S302
已完成
3 期
Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT03136484Novo Nordisk A/S788
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)DiabetesDiabetes Mellitus, Type 2NCT03061214Novo Nordisk A/S868
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01885208Novo Nordisk A/S813