Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,606
- 试验地点
- 224
- 主要终点
- Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
研究概览
简要总结
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.
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
- •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 180 days prior to the day of screening.
- •HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
- •BMI equal to or above 25 kg/m^2
- •Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
- •No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:
- •Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
- •Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
- •Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
- •Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
- •Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
排除标准
- •Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
研究组 & 干预措施
Oral semaglutide 50 mg
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).
干预措施: Oral semaglutide (Drug)
Oral semaglutide 25 mg
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).
干预措施: Oral semaglutide (Drug)
Oral semaglutide 14 mg
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).
干预措施: Oral semaglutide (Drug)
结局指标
主要结局
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
时间窗: Baseline (week 0), week 52
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
次要结局
- Change From Baseline in Body Weight (Week 52)(Baseline (week 0), week 52)
- Time to Event Analyses of Rescue Medication(Baseline (week 0), week 68)
- Change From Baseline in HbA1c (Week 68)(Baseline (week 0), week 68)
- Change From Week 12 in HbA1c (Week 52)(Week 12, Week 52)
- Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)(At week 68)
- Change From Baseline in Waist Circumference (Week 68)(Baseline (week 0), week 68)
- Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)(Baseline (week 0), week 52)
- Change From Baseline in FPG (Week 68)(Baseline (week 0), week 68)
- Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)(At week 52)
- Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)(At week 52)
- Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)(At week 68)
- Percentage Change From Baseline in Body Weight (Week 52)(Baseline (week 0), week 52)
- Percentage Change From Week 12 in Body Weight (Week 52)(Week 12, Week 52)
- Change From Baseline in BMI (Week 68)(Baseline (week 0), week 68)
- Change From Baseline in Waist Circumference (Week 52)(Baseline (week 0), week 52)
- Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)(At week 68)
- Change From Baseline in Body Weight (Week 68)(Baseline (week 0), week 68)
- Percentage Change From Baseline in Body Weight (Week 68)(Baseline (week 0), week 68)
- Change From Baseline in Body Mass Index (BMI) (Week 52)(Baseline (week 0), week 52)
- Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)(At week 68)
- Change From Baseline in High Density Lipoproteins (HDL) (Week 52)(Baseline, Week 52)
- Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)(At week 52)
- Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)(At week 52)
- Change From Baseline in Triglycerides (Week 68)(Baseline, Week 68)
- Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)(From baseline (week 0) up to week 68)
- Change From Baseline in Systolic Blood Pressure (Week 52)(Baseline (week 0), week 52)
- Change From Baseline in Systolic Blood Pressure (Week 68)(Baseline (week 0), week 68)
- Change From Baseline in Total Cholesterol (Week 52)(Baseline, Week 52)
- Change From Baseline in Total Cholesterol (Week 68)(Baseline, Week 68)
- Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)(Baseline, Week 52)
- Change From Baseline in LDL (Week 68)(Baseline, Week 68)
- Change From Baseline in Triglycerides (Week 52)(Baseline, Week 52)
- Change From Baseline in HDL (Week 68)(Baseline, Week 68)
- Number of Adverse Events(From baseline (week 0) up to week 73)
- Change From Baseline in Pulse (Week 68)(Baseline (week 0), week 68)
- Change From Baseline in Diastolic Blood Pressure (Week 52)(Baseline (week 0), week 52)
- Change From Baseline in Pulse (Week 52)(Baseline (week 0), week 52)
- Change From Baseline in Diastolic Blood Pressure (Week 68)(Baseline (week 0), week 68)