NCT03136484已完成3 期
Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes
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
- 788
- 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 Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin
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 equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - 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) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - 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 (DKA) - Any of the following: myocardial infarction (MI), 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 eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - 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 - 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 - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening
研究组 & 干预措施
Semaglutide + canagliflozin placebo
Experimental
干预措施: Semaglutide (Drug)
Semaglutide + canagliflozin placebo
Experimental
干预措施: Placebo (canagliflozin) (Drug)
Canagliflozin + semaglutide placebo
Active Comparator
干预措施: Canagliflozin (Drug)
Canagliflozin + semaglutide placebo
Active Comparator
干预措施: Placebo (semaglutide) (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0, week 52
Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first.
次要结局
- Change in Body Weight (kg)(Week 0, week 52)
- Change in Total Fat Mass (kg)(Week 0, week 52)
- Change in FPG (Fasting Plasma Glucose)(Week 0, week 52)
- Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile(Week 0, week 52)
- Change in SMPG- Mean Postprandial Increment Over All Meals(Week 0, week 52)
- Change in Fasting Total Cholesterol(Week 0, week 52)
- Change in Fasting LDL-cholesterol(Week 0, week 52)
- Change in Fasting HDL-cholesterol(Week 0, week 52)
- Change in Fasting Triglycerides(Week 0, week 52)
- Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)(Week 0, week 52)
- Percentage Change in Body Weight (%)(Week 0, week 52)
- Change in Body Mass Index (BMI)(Week 0, week 52)
- Change in Waist Circumference(Week 0, week 52)
- Percentage Change in Total Fat Mass (%)(Week 0, week 52)
- Change in Total Lean Mass (kg)(Week 0, week 52)
- Percentage Change in Total Lean Mass (%)(Week 0, week 52)
- Change in Visceral Fat Mass (kg)(Week 0, week 52)
- Percentage Change in Visceral Fat Mass (%)(Week 0, week 52)
- Change in Ratio Between Total Fat Mass and Total Lean Mass(Week 0, week 52)
- Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)(Week 52)
- Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)(Week 52)
- Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)(Week 0, week 52)
- Participants Who Achieved Weight Loss ≥3% (Yes/no)(Week 0, week 52)
- Participants Who Achieved Weight Loss ≥5% (Yes/no)(Week 0, week 52)
- Participants Who Achieved Weight Loss ≥10% (Yes/no)(Week 0, week 52)
- Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)(Week 0, week 52)
- Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)(Week 0, week 52)
- Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)(Week 0, week 52)
- Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)(Week 0, week 52)
- Total Number of Treatment Emergent Adverse Events (TEAEs)(Weeks 0-57)
- Change in Haematological Parameter- Haemoglobin(Week 0, week 52)
- Change in Haematological Parameter- Haematocrit(Week 0, week 52)
- Change in Haematological Parameter- Erythrocytes(Week 0, week 52)
- Change in Haematological Parameter- Leukocytes(Week 0, week 52)
- Change in Haematological Parameter- Thrombocytes(Week 0, week 52)
- Change in Biochemistry Parameter- Amylase(Week 0, week 52)
- Change in Biochemistry Parameter- Lipase(Week 0, week 52)
- Change in Biochemistry Parameter- ALT(Week 0, week 52)
- Change in Biochemistry Parameter- AST(Week 0, week 52)
- Change in Biochemistry Parameter- ALP(Week 0, week 52)
- Change in Biochemistry Parameter- Total Bilirubin(Week 0, week 52)
- Change in Biochemistry Parameter- Creatinine(Week 0, week 52)
- Change in Biochemistry Parameter- eGFR(Week 0, week 52)
- Change in Biochemistry Parameter- Albumin(Week 0, week 52)
- Change in Biochemistry Parameter- Calcium(Week 0, week 52)
- Change in Biochemistry Parameter- Potassium(Week 0, week 52)
- Change in Biochemistry Parameter- Sodium(Week 0, week 52)
- Change in Calcitonin(Week 0, week 52)
- Change in Pulse(Week 0, week 52)
- Change in ECG(Week 0, week 52)
- Change in Physical Examination(Week -2, week 52)
- Eye Examination(Week 0, week 52)
- Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-57)
- Change in Short Form 36 Health Survey (SF-36): Sub-domains(Week 0, week 52)
- Change in CoEQ: Individual Items(Week 0, week 52)
- Change in SF-36: Physical Component Summary (PCS)(Week 0, week 52)
- Change in SF-36: Mental Component Summary (MCS)(Week 0, week 52)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately(Week 0, week 52)
- Change in Control of Eating Questionnaire (CoEQ): Domains(Week 0, week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)DiabetesDiabetes Mellitus, Type 2NCT03061214Novo Nordisk A/S868
已完成
3 期
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01930188Novo Nordisk A/S1,231
已完成
3 期
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02128932Novo Nordisk A/S1,089
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 MellitusDiabetesDiabetes Mellitus, Type 2NCT03086330Novo Nordisk A/S302
已完成
3 期
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.Diabetes Mellitus, Type 2DiabetesNCT02648204Novo Nordisk A/S1,201