NCT02863328已完成3 期
Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- Change in HbA1c
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 Empagliflozin 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
- 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
- •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
- •Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening
- •HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive)
- •Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of 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 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 or Medullary Thyroid Carcinoma
- •History of pancreatitis (acute or chronic)
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •Any of the following: myocardial infarction, 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 Class IV
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Subjects with ALT (alanine aminotransferase) above 2.5 x upper normal limit
- •Renal impairment defined as Estimated Glomerular Filtration Rate 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
14 mg oral semaglutide
Experimental
干预措施: semaglutide (Drug)
25 mg empagliflozin
Active Comparator
干预措施: empagliflozin (Drug)
结局指标
主要结局
Change in HbA1c
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 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 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.
次要结局
- Change in Body Weight (kg)(Week 0, week 52)
- Change in SMPG : Mean of the 7-point Profile(Week 0, week 26 and week 52)
- Change in HOMA-B (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in HbA1c (%)(Week 0, week 52)
- Change in Fasting Plasma Glucose(Week 0, week 26, week 52)
- Change in Body Weight (Kg)(Week 0, week 26)
- Change in Fasting VLDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Time to Additional Anti-diabetic Medication(Weeks 0-52)
- Number of Treatment-emergent Adverse Events (TEAE)(Weeks 0-57)
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure)(Week 0, week 26, week 52)
- Change in SMPG : Mean Postprandial Increment Over All Meals(Week 0, week 26 and week 52)
- Change in Fasting Insulin (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in HOMA-IR (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Body Mass Index(Week 0, week 26, week 52)
- Change in Fasting HDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)(Week 26 and week 52)
- Change in Fasting Pro-insulin (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting Glucagon (Ratio to Baseline)(Week 0, week 26 and week 52)
- Participants Who Achieve Weight Loss ≥10% (Yes/no)(Week 26 and week 52)
- Change in Amylase (Ratio to Baseline)(Week 0, week 26, week 52)
- Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)(Weeks 0-57)
- Change in Fasting C-peptide (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Body Weight (%)(Week 0, week 26, week 52)
- Change in Waist Circumference(Week 0, week 26, week 52)
- Change in Fasting Free Fatty Acids (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting Triglycerides (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in ECG(Week 0, week 26, week 52)
- Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Weeks 0-57)
- Anti-semaglutide Binding Antibody Levels(Weeks 0-57)
- Change in C-reactive Protein (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting Total Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting LDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) ADA Target (Yes/no)(Week 26 and week 52)
- Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)(Week 26 and week 52)
- Participants Who Achieve Weight Loss ≥5% (Yes/no)(Week 26 and 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 and week 52)
- Change in Lipase (Ratio to Baseline)(Week 0, week 26, week 52)
- Time to Rescue Medication(Weeks 0-52)
- Change in Pulse Rate(Week 0, week 26, week 52)
- Change in Eye Examination(Week -2, week 52)
- SNAC Plasma Concentrations(Weeks 0-52)
- Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)(Weeks 0-57)
- Change in Physical Examination(Week -2, week 52)
- Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)(Weeks 0-57)
- Semaglutide Plasma Concentrations for Population PK Analyses(Weeks 0-52)
- Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Weeks 0-57)
- Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)(Week 0, week 26, week 52)
- Change in CoEQ: Scores From the 4 Domains and the 19 Items(Week 0, week 26, week 52)
研究者
研究点 (1)
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