NCT03086330已完成3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial
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
- 302
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
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, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus
- •HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- •Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label
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)
- •Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- •Treatment with any medication for the indication 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
- •Subjects with alanine aminotransferase above 2.5 x upper normal limit
- •Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative
- •History or presence of pancreatitis (acute or chronic)
- •History of diabetic ketoacidosis
- •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 Class IV
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening
- •Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
- •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
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 30
Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.
次要结局
- Change in Body Weight (kg)(Week 0, week 30)
- Change in Fasting Plasma Glucose (FPG)(Week 0, week 30)
- Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile(Week 0, week 30)
- Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)(Week 0, week 30)
- Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol(Week 0, week 30)
- Change in Body Weight (%)(Week 0, week 30)
- Change in Fasting Blood Lipid, Total Cholesterol(Week 0, week 30)
- Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol(Week 0, week 30)
- Change in Diastolic Blood Pressure(Week 0, week 30)
- HbA1c Below 7.0% (53 mmol/Mol)(After 30 weeks)
- Change in Fasting Blood Lipid, Triglycerides(Week 0, week 30)
- Change in Body Mass Index(Week 0, week 30)
- Change in Waist Circumference(Week 0, week 30)
- Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains(Week 0, week 30)
- HbA1c Equal to or Below 6.5% (48 mmol/Mol)(After 30 weeks)
- Change in Systolic Blood Pressure(Week 0, week 30)
- Weight Loss Equal to or Above 3%(After 30 weeks)
- Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately(Week 0, week 30)
- Weight Loss Equal to or Above 5%(After 30 weeks)
- Weight Loss Equal to or Above 10%(After 30 weeks)
- HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain(After 30 weeks)
- HbA1c Reduction Equal to or Above 1%-Point(After 30 weeks)
- HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%(After 30 weeks)
- HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%(After 30 weeks)
- HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%(After 30 weeks)
- Number of Treatment-emergent Adverse Events (TEAEs)(Week 0 - week 30)
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Week 0 - week 30)
- Change in Haematology: Haemoglobin(Week 0, week 30)
- Change in Haematology: Haematocrit(Week 0, week 30)
- Change in Haematology: Thrombocytes(Week 0, week 30)
- Change in Biochemistry: Bicarbonate(Week 0, week 30)
- Change in Biochemistry: Creatinine(Week 0, week 30)
- Change in Calcitonin(Week 0, week 30)
- Change in Haematology: Erythrocytes(Week 0, week 30)
- Change in Haematology: Leucocytes(Week 0, week 30)
- Change in Biochemistry: Amylase(Week 0, week 30)
- Change in Biochemistry: Aspartate Aminotransferase(Week 0, week 30)
- Change in Biochemistry: Total Bilirubin(Week 0, week 30)
- Change in Biochemistry: Lipase(Week 0, week 30)
- Change in Biochemistry: Alkaline Phosphatase(Week 0, week 30)
- Change in Biochemistry: Alanine Aminotransferase(Week 0, week 30)
- Change in Biochemistry: Albumin(Week 0, week 30)
- Change in Biochemistry: Calcium (Total)(Week 0, week 30)
- Change in Biochemistry: Potassium(Week 0, week 30)
- Change in Biochemistry: Sodium(Week 0, week 30)
- Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)(Week 0, week 30)
- Change in Pulse(Week 0, week 30)
- Change in Electrocardiogram(Week 0, week 30)
- Change in Physical Examination: General Appearance(Week -2, week 30)
- Change in Physical Examination: Central and Peripheral Nervous System(Week -2, week 30)
- Change in Physical Examination: Cardiovascular System(Week -2, week 30)
- Change in Physical Examination: Skin(Week -2, week 30)
- Change in Physical Examination: Gastrointestinal System Including Mouth(Week -2, week 30)
- Change in Physical Examination: Respiratory System(Week -2, week 30)
- Change in Fundoscopy(Week 0, week 30)
- Change in Physical Examination: Lymph Node Palpation(Week -2, week 30)
- Change in Physical Examination: Thyroid Gland(Week -2, week 30)
研究者
研究点 (1)
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