NCT03015220已完成3 期
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese 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
- 458
- 试验地点
- 1
- 主要终点
- Number of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese 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
- 20 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
- •Japanese male or female, age above or equal to 20 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening
- •HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)
- •OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling
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 are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
- •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 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 (TIA) within the past 180 days prior to the day of screening and randomisation
- •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 alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
- •Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
- •Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening
- •For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening
- •Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 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 in situ carcinomas)
- •History of diabetic ketoacidosis
研究组 & 干预措施
Oral semaglutide 3 mg
Experimental
干预措施: Semaglutide (Drug)
Oral semaglutide 7 mg
Experimental
干预措施: Semaglutide (Drug)
Oral semaglutide 14 mg
Experimental
干预措施: Semaglutide (Drug)
Dulaglutide 0.75 mg
Active Comparator
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Number of Treatment-emergent Adverse Events (TEAEs)
时间窗: Weeks 0-57
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
次要结局
- Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals(Week 0, week 26, week 52)
- Change in Body Mass Index (BMI)(Week 0, week 26, week 52)
- Change in Pulse Rate(Week 0, week 26, week 52)
- Change in Blood Pressure(Week 0, week 26, week 52)
- Change in ECG Evaluation(Week 0, week 26, week 52)
- Change in Physical Examination(Week -2, week 26, week 52)
- Change in HbA1c(Week 0, week 26, week 52)
- Change in Body Weight (%)(Week 0, week 26, week 52)
- Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)(Week 26, week 52)
- Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)(Week 26, week 52)
- Change in Fasting Plasma Glucose(Week 0, week 26, week 52)
- Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile(Week 0, week 26, week 52)
- Change in Body Weight (kg)(Week 0, week 26, week 52)
- Change in Fasting Total Cholesterol (Ratio to Baseline)(Week 0, week 26, week 52)
- Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)(Week 0, week 26, week 52)
- Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)(Week 0, week 26, week 52)
- Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)(Week 0, week 26, week 52)
- Change in Fasting Triglyceride (Ratio to Baseline)(Week 0, week 26, week 52)
- Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)(Week 26, week 52)
- Change in Lipase (Ratio to Baseline)(Week 0, week 26, week 52)
- Change in Waist Circumference(Week 0, week 26, week 52)
- Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)(Week 26, week 52)
- Time to Additional Anti-diabetic Medication(Weeks 0-52)
- Time to Rescue Medication(Weeks 0-52)
- Change in Eye Examination Category(Week -2, week 52)
- Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains(week 0, week 26, week 52)
- Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)(Week 26, week 52)
- Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).(Week 26, week 52)
- Change in Amylase (Ratio to Baseline)(Week 0, week 26, week 52)
- Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)(Week 0, week 26, week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT03018028Novo Nordisk A/S243
已完成
3 期
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With InsulinDiabetesDiabetes Mellitus, Type 2NCT03021187Novo Nordisk A/S731
已完成
3 期
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal ImpairmentDiabetesDiabetes Mellitus, Type 2NCT02827708Novo Nordisk A/S324
已完成
3 期
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise OnlyDiabetes Mellitus, Type 2DiabetesNCT02906930Novo Nordisk A/S703
已完成
3 期
Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT02863328Novo Nordisk A/S822