NCT02827708已完成3 期
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment
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
- 324
- 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 and moderate renal impairment.
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
- •Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening
- •HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive)
- •Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
- •Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens:
- •1-2 of the following oral anti-diabetic drugs:
- •Metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record),
- •Sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
- •Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) or
- •Metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)
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 certain specific countries: Additional specific requirements apply
- •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 Carcinoma
- •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
- •Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g)
- •Use of systemic immunosuppressive treatment within 90 days prior to screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria 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
- •Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator
- •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 carcinoma in situ)
研究组 & 干预措施
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) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated 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 rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
次要结局
- Change in Waist Circumference(Week 0, week 26)
- Participants Who Achieve Weight Loss ≥5% (Yes/no)(Week 26)
- Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)(Week 26)
- Change in Body Weight (kg)(Week 0, week 26)
- Change in Body Weight (%)(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)
- Change in Total Cholesterol (Ratio to Baseline)(Week 0, week 26)
- Change in FPG(Week 0, week 26)
- Participants Who Achieve HbA1c <7.0% (53 mmol/Mol), ADA Target (Yes/no)(Week 26)
- Participants Who Achieve Weight Loss ≥10% (Yes/no)(Week 26)
- Change in HDL Cholesterol (Ratio to Baseline)(Week 0, week 26)
- Number of TEAEs(Weeks 0-31)
- Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)(Week 26)
- Change in LDL Cholesterol (Ratio to Baseline)(Week 0, week 26)
- Time to Rescue Medication(Weeks 0-26)
- Change in Triglycerides (Ratio to Baseline)(Week 0, week 26)
- Time to Additional Anti-diabetic Medication(Weeks 0-26)
- Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-31)
- Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)(Weeks 0-31)
- Change in Lipase (Ratio to Baseline)(Week 0, week 26)
- Change in Pulse Rate(Week 0, week 26)
- Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)(Weeks 0-31)
- Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Weeks 0-31)
- Change in CRP (Ratio to Baseline)(Week 0, week 26)
- Change in Amylase (Ratio to Baseline)(Week 0, week 26)
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure)(Week 0, week 26)
- Change in Urinary Albumin to Creatinine Ratio (Ratio to Baseline)(Week 0, week 26)
- Change in ECG(Week 0, week 26)
- Change in Physical Examination(Week -2, week 26)
- Change in Eye Examination(Week -2, 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)
- Anti-semaglutide Binding Antibody Levels(Weeks 0-31)
- Semaglutide Plasma Concentrations for Population PK Analyses(Weeks 0-26)
- SNAC Plasma Concentrations(Weeks 0-26)
- Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)(Week 0, week 26)
- Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)(Week 0, week 26)
- Change in Urinalysis(Week -2, week 26)
研究者
研究点 (1)
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