NCT02906930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 Only.
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
- 703
- 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 placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.
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 above or equal to 20 years at the time of signing informed consent. For Algeria only: Male or female, age above or equal to 19 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 (glycosylated haemoglobin) between 7.0-9.5% (53-80 mmol/mol) (both inclusive) - Treatment with diet and exercise for at least 30 days prior to 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 Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.For Czech Republic only: Adequate contraceptive measures are always one highly reliable method (such as intrauterine device, sterilisation of one of the partners, hormonal birth control methods) plus one supplementary barrier method (such as condom, diaphragm) with a spermicide. In justified cases, this combination may be replaced with a double-barrier method with a spermicide. Total sexual abstinence may also be considered contraception. (Please note: hormonal contraception should always be discussed with a gynaecologist) - 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 carcinomas - 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 and randomisation - 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 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 - Treatment with any medication for the indication of diabetes or obesity 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 in-situ carcinomas)
研究组 & 干预措施
3 mg oral semaglutide
Experimental
干预措施: semaglutide (Drug)
7 mg oral semaglutide
Experimental
干预措施: semaglutide (Drug)
14 mg oral semaglutide
Experimental
干预措施: semaglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0, week 26
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication.
次要结局
- Change in Fasting Glucagon - Ratio to Baseline(Week 0, week 26)
- Change in HOMA-B (Beta-cell Function) - Ratio to Baseline(Week 0, week 26)
- Change in CRP - Ratio to Baseline(Week 0, week 26)
- Change in Body Weight (%)(Week 0, week 26)
- Change in Fasting HDL Cholesterol - Ratio to Baseline(Week 0, week 26)
- Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no)(Week 26)
- Change in Fasting LDL Cholesterol - Ratio to Baseline(Week 0, week 26)
- Change in Fasting Triglycerides - Ratio to Baseline(Week 0, week 26)
- Change in Waist Circumference(Week 0, week 26)
- Change in Body Weight (kg)(Week 0, week 26)
- Change in Fasting Plasma Glucose(Week 0, week 26)
- Change in Mean 7-point SMPG Profile(Week 0, week 26)
- Change in Mean Postprandial Increment Over All Meals in SMPG(Week 0, week 26)
- Change in BMI(Week 0, week 26)
- Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no)(Week 26)
- Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no)(Week 26)
- Change in Fasting Insulin - Ratio to Baseline(Week 0, week 26)
- Change in Fasting Pro-insulin - Ratio to Baseline(Week 0, week 26)
- Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline(Week 0, week 26)
- Change in Fasting Total Cholesterol - Ratio to Baseline(Week 0, week 26)
- Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no)(Week 26)
- Change in Physical Examination(Week 0, week 26)
- Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no)(Week 26)
- Number of Treatment-emergent Adverse Events (TEAEs)(Approximately upto week 31)
- Change in Amylase - Ratio to Baseline(Week 0, week 26)
- Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no)(Week 26)
- Time to Additional Anti-diabetic Medication(Weeks 0-26)
- Time to Rescue Medication(Weeks 0-26)
- Change in Lipase - Ratio to Baseline(Week 0, week 26)
- Change in Pulse Rate(Week 0, week 26)
- Change in Eye Examination Category(Week 0, week 26)
- Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)(Weeks 0-31)
- Change in Systolic Blood Pressure (SBP)(Week 0, week 26)
- Change in Diastolic Blood Pressure (DBP)(Week 0, week 26)
- Change in Electrocardiogram (ECG) Evaluation(Week 0, week 26)
- Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)(Weeks 0-31)
- Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Weeks 0-31)
- Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Weeks 0-31)
- Anti-semaglutide Binding Antibody Levels(Weeks 0-31)
- Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product(Weeks 0-31)
- Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product(Weeks 0-31)
- SNAC Plasma Concentrations(Weeks 0-26)
- Semaglutide Plasma Concentrations for Population PK Analysis(Weeks 0 - 26)
- Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)(Week 0, week 26)
- IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire)(Week 0, week 26)
- PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire)(Week 26)
- PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire)(Week 26)
研究者
研究点 (1)
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