NCT02863419已完成3 期
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
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
- 711
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Week 26)
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus.
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
- Double (Participant, Investigator)
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
- •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. For Japan only: Male or female, age at least 20 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening.
- •HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)
- •Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed)
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 measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- •Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
- •History of pancreatitis (acute or chronic)
- •History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •Any of the following: myocardial infarction (MI), stroke or hospitalisation 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
- •Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)
- •Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
- •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 the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days
- •Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
- •History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
- •History of diabetic ketoacidosis
研究组 & 干预措施
Oral Semaglutide
Experimental
干预措施: semaglutide (Drug)
Liraglutide
Active Comparator
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c (Week 26)
时间窗: Week 0, week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
次要结局
- Change in HbA1c (Week 52)(Week 0, week 52)
- Change in Free Fatty Acids - Ratio to Baseline(Week 0, week 26, week 52)
- Change in SMPG - Mean Postprandial Increment Over All Meals(Week 0, week 26, week 52)
- Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)(Week 26, week 52)
- Participants Who Achieve Weight Loss ≥5% (Yes/no)(Week 26, week 52)
- Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)(Week 26, week 52)
- Time to Additional Anti-diabetic Medication(Weeks 0-52)
- Change in Body Weight (Week 26)(Week 0, week 26)
- Change in Body Mass Index(Week 0, week 26, week 52)
- Change in Total Cholesterol - Ratio to Baseline(Week 0, week 26, week 52)
- Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline(Week 0, week 26, week 52)
- Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline(Week 0, week 26, week 52)
- Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)(Week 26, week 52)
- Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product(Weeks 0-57)
- Change in Body Weight (Week 52)(Week 0, week 52)
- Change in Fasting Plasma Glucose(Week 0, week 26, week 52)
- Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline(Week 0, week 26, week 52)
- Change in Waist Circumference(Week 0, week 26, week 52)
- Participants Who Achieve Weight Loss ≥ 10% (Yes/no)(Week 26, week 52)
- Change in Body Weight (%)(Week 0, Week 26, Week 52)
- Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)(Week 26, week 52)
- Change in Physical Examination(Week -2, week 52)
- Time to Rescue Medication(Weeks 0-52)
- Change in Triglycerides - Ratio to Baseline(Week 0, week 26, week 52)
- Change in SMPG - Mean 7-point Profile(Week 0, week 26, week 52)
- Change in Amylase - Ratio to Baseline(Week 0, week 26, week 52)
- Change in Lipase - Ratio to Baseline(Week 0, week 26, week 52)
- Change in Pulse Rate(Week 0, week 26, week 52)
- Change in SBP and DBP(Week 0, week 26, week 52)
- Change in ECG Evaluation(Week 0, week 26, week 52)
- Change in Eye Examination Category(Week -2, Week 52)
- Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)(Weeks 0-57)
- Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Week 0-57)
- Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Weeks 0-57)
- Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)(Week 0, week 26, week 52)
- Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)(Weeks 0-57)
- Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Anti-semaglutide Binding Antibody Levels(Weeks 0-57)
研究者
研究点 (1)
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