Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,274
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycated Haemoglobin (HbA1c)
研究概览
简要总结
This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.
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
- None
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 greater than or equal to 18 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening
- •Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening
- •Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors
- •Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)
排除标准
- •History or presence of pancreatitis (acute or chronic)
- •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
- •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 bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in
研究组 & 干预措施
Semaglutide
Run-in period (12 weeks): subjects will be treated with metformin and insulin glargine (IGlar) U100.
Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in will receive semaglutide for 52 weeks in addition to metformin and IGlar U100.
Metformin will be considered as background therapy during the trial.
干预措施: Semaglutide (Drug)
Semaglutide
Run-in period (12 weeks): subjects will be treated with metformin and insulin glargine (IGlar) U100.
Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in will receive semaglutide for 52 weeks in addition to metformin and IGlar U100.
Metformin will be considered as background therapy during the trial.
干预措施: Insulin glargine U100 (Drug)
Insulin aspart
Run-in period (12 weeks): subjects will be treated with metformin and insulin IGlar U100.
Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in receive insulin aspart for 52 weeks in addition to metformin and IGlar U100.
Metformin will be considered as background therapy during the trial.
干预措施: Insulin aspart (Drug)
Insulin aspart
Run-in period (12 weeks): subjects will be treated with metformin and insulin IGlar U100.
Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in receive insulin aspart for 52 weeks in addition to metformin and IGlar U100.
Metformin will be considered as background therapy during the trial.
干预措施: Insulin glargine U100 (Drug)
结局指标
主要结局
Change From Baseline in Glycated Haemoglobin (HbA1c)
时间窗: Baseline (week 0), week 52
Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
次要结局
- Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Body Mass Index (BMI)(Baseline (week 0), week 52)
- Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52(From randomization (week 0) up to week 52)
- Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52(From randomization (week 0) to week 52)
- Total Daily Insulin Dose at Week 52(At week 52)
- Change From Baseline to Week 52 in Body Weight (Kilogram (kg))(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Pulse Rate(Baseline (week 0), week 52)
- Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52(From randomization (week 0) up to week 52)
- Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52(From randomization (week 0) to week 52)
- Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52(From randomization (week 0) to week 52)
- Daily Basal Insulin Dose at Week 52(At week 52)
- Change From Baseline to Week 52 in Waist Circumference(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)(Baseline (week 0), week 52)
- Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52(From randomization (week 0) to week 52)
- Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52(From randomization (week 0) to week 52)
- Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure(Baseline (week 0), week 52)
- Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains(Baseline (week 0), week 52)