China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 66
- 主要终点
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
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 Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent.
- •For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus
- •HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).
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 highly effective contraceptive method.
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.
- •History or presence 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, hospitalization 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.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI).
- •Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).
- •Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
研究组 & 干预措施
Oral semaglutide 3mg
Subjects will remain on 3 mg for the entire treatment period (26 weeks)
干预措施: Oral semaglutide (Drug)
Oral semaglutide 7mg
Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period
干预措施: Oral semaglutide (Drug)
Oral semaglutide 14mg
Subjects will receive 3 mg for the first 4 weeks, 7 mg for the next 4 weeks and 14 mg for the remainder of the treatment period
干预措施: Oral semaglutide (Drug)
Placebo (oral semaglutide)
Subjects will receive placebo tablets for the entire treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
时间窗: Baseline (Week 0), Week 26
Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline (Week 0), Week 26)
- Change From Baseline in Body Weight (Kilograms [kg])(Baseline (Week 0), Week 26)
- Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)(Baseline (Week 0), Week 26)
- Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile(Baseline (Week 0), Week 26)
- Change From Baseline in Body Weight (Percentage [%])(Baseline (Week 0), Week 26)
- Change From Baseline in Waist Circumference(Baseline (Week 0), Week 26)
- Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey(Baseline (Week 0), Week 26)
- Change From Baseline in Body Mass Index (BMI)(Baseline (Week 0), Week 26)
- Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)(Week 26)
- Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)(Week 26)
- Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)(Week 26)
- Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)(Week 26)
- Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Urea (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)(Week 26)
- Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)(Week 26)
- Time From First Dose to Initiation of Rescue Medication(From baseline (Week 0) to Week 26)
- Change From Baseline in Potassium (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Semaglutide Plasma Concentrations(Week 26: post dose any time)
- Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(Up to 31 weeks)
- Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)(Week 26)
- Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)(Week 26)
- Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Calcium (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Sodium (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Albumin (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Calcitonin (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Diastolic Blood Pressure(Baseline (Week 0), Week 26)
- Change From Baseline in Physical Examination Category(Baseline (Week 0), Week 26)
- Change From Baseline in Eye Examination Category(Baseline (Week 0), Week 26)
- Number of Treatment-emergent Adverse Events (TEAEs)(Up to 31 weeks)
- Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Up to 31 weeks)
- Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)(Baseline (Week 0), Week 26)
- Change From Baseline in Pulse Rate(Baseline (Week 0), Week 26)
- Change From Baseline in Systolic Blood Pressure(Baseline (Week 0), Week 26)
- Change From Baseline in Electrocardiogram (ECG) Category(Baseline (Week 0), Week 26)
- Anti-semaglutide Binding Antibody Levels(Up to 31 weeks)
- Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1(Up to 31 weeks)
- Number of Participants With Anti-semaglutide Binding Antibodies(Up to 31 weeks)