Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy and Treated in a Primary Care Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,991
- 试验地点
- 1
- 主要终点
- Time to Inadequate Glycaemic Control
研究概览
简要总结
This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.
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 at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Liraglutide 1.8 mg
Add-on to metformin
干预措施: liraglutide (Drug)
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
干预措施: alpha-glucosidase inhibitors (Drug)
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
干预措施: DPP-4 inhibitors (Drug)
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
干预措施: meglitinides (Drug)
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
干预措施: SGLT-2 inhibitors (Drug)
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
干预措施: sulphonylurea (Drug)
OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
干预措施: thiazolidinediones (Drug)
结局指标
主要结局
Time to Inadequate Glycaemic Control
时间窗: Weeks 26-104
Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.
次要结局
- Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes(Week 104/Premature treatment discontinuation)
- Change in Body Weight(Week 0, week 104/premature treatment discontinuation)
- Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides(Week 0, week 104/premature treatment discontinuation)
- Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)(Weeks 0-104)
- Participants Who Achieve HbA1c ≤7.0% Without Weight Gain(Week 104/Premature treatment discontinuation)
- Change in Fasting Plasma Glucose (FPG)(Week 0, week 104/premature treatment discontinuation)
- Participants Who Achieve HbA1c ≤6.5% (Yes/No)(Week 104/Premature treatment discontinuation)
- Change in HbA1c(Week 0, week 104/premature treatment discontinuation)
- Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum(Week 0, week 104/premature treatment discontinuation)
- Change in Haemoglobin(Week 0, week 104/premature treatment discontinuation)
- Change in Pulse(Week 0, week 104/premature treatment discontinuation)
- Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes(Week 104/Premature treatment discontinuation)
- Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)(Weeks 0-104)
- Number of Serious Adverse Events (SAEs)(Weeks 0-105)
- Number of AEs Leading to Permanent Discontinuation of Trial Product(Weeks 0-105)
- Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase(Week 0, week 104/premature treatment discontinuation)
- Change in Body Mass Index (BMI)(Week 0, week 104/premature treatment discontinuation)
- Number of Severe Hypoglycaemic Episodes(Weeks 0-104)
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure)(Week 0, week 104/premature treatment discontinuation)
- Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-104)
- Change in Biochemistry- Creatinine, Total Bilirubin(Week 0, week 104/premature treatment discontinuation)
- Change in Potassium(Week 0, week 104/premature treatment discontinuation)