NCT03018028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 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
- 243
- 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 in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese 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
- 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 30 days prior to day of screening
- •HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone
- •Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone
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 and 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 and randomisation
- •Subject 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 agonist (GLP-1 RA), once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90 days before the day of screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 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 in-situ carcinomas)
- •Initiation of anti-diabetic medication between the day of screening and the day of randomisation
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)
Oral placebo
Placebo Comparator
干预措施: Placebo (Drug)
Liraglutide 0.9 mg
Active Comparator
干预措施: Liraglutide (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) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - 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.
次要结局
- Change in HbA1c (Week 52)(Week 0, week 52)
- Change in Fasting Plasma Glucose(Week 0, week 26, week 52)
- Change in VLDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting Insulin (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting C-peptide (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting Pro-insulin (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Body Weight (kg)(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 (%)(Week 0, week 26 and week 52)
- Change in Waist Circumference(Week 0, week 26 and week 52)
- Change in Fasting Glucagon (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)(Week 0, week 26 and week 52)
- Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)(Week 26 and week 52)
- Change in Mean Postprandial Increment Over All Meals in SMPG(Week 0, week 26 and week 52)
- Change in Body Mass Index(Week 0, week 26 and week 52)
- Change in Total Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in HDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in LDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
- Change in Triglycerides (Ratio to Baseline)(Week 0, week 26 and week 52)
- Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)(Week 26 and week 52)
- Change in Physical Examination(Baseline (Week -8), week 26, week 52)
- Anti-semaglutide Neutralising Antibodies (Yes/no)(Week 0 - 57)
- Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)(Week 26 and week 52)
- Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)(Week 26 and week 52)
- Time to Rescue Medication(Weeks 0 - 52)
- Anti-semaglutide Binding Antibodies (Yes/no)(Week 0 - 57)
- Anti-semaglutide Binding Antibody Levels(Weeks 0-57)
- Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%(Week 26 and week 52)
- Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)(Week 26 and week 52)
- Change in Amylase (Ratio to Baseine)(Week 0, week 26, week 52)
- Change in Lipase (Ratio to Baseine)(Week 0, week 26, week 52)
- Change in Pulse Rate(Week 0, week 26, week 52)
- Change in ECG Evaluation(Week 0, week 26, week 52)
- Time to Additional Anti-diabetic Medication(Weeks 0 - 52)
- Number of Treatment-emergent Adverse Events (TEAEs)(Weeks 0 - 57)
- Change in Blood Pressure(Week 0, week 26, week 52)
- Change in Eye Examination Category(Week -8, Week 52)
- Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Week 0 - 57)
- Change From Baseline in DTR-QOL: Total Score(Week 0, week 26, week 52)
- Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Week 0 - 57)
- Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Week 0 - 57)
- Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0 - 57)
- Semaglutide Plasma Concentration(Week 26 and week 52)
- Change in SF-36: Sub-domains(Week 0, week 26, week 52)
- Change From Baseline in DTR-QOL: Sub-domains(Week 0, week 26, week 52)
- Change in SF-36: Physical Component Summary (PCS)(Week 0, week 26, week 52)
- Change in SF-36: 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
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT03015220Novo Nordisk A/S458
已完成
3 期
A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02207374Novo Nordisk A/S601
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
已完成
3 期
Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.DiabetesDiabetes Mellitus, Type 2NCT02849080Novo Nordisk A/S504
已完成
3 期
Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02607865Novo Nordisk A/S1,864