A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Emergent Adverse Events (AEs)
研究概览
简要总结
This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.
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
- 20 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 would not have been performed during normal management of the subject.)
- •Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
- •Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
- •HbA1c between 7.0-10.0% (both inclusive)
- •Body Mass Index (BMI) below 40.0 kg/m^2
- •Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
- •Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)
排除标准
- •Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
- •Calcitonin above or equal to 160 pg/mL
- •Personal history of non-familial medullary thyroid carcinoma
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
- •Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)
研究组 & 干预措施
Liraglutide + an OAD therapy
干预措施: liraglutide (Drug)
Two OADs combination therapy
干预措施: oral anti-diabetic drug (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (AEs)
时间窗: Week 0 to Week 52 + 7 days
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.
次要结局
- Number of Confirmed Hypoglycaemic Episodes(Week 0 to Week 52)
- Change in HbA1c From Baseline to Week 52(Week 0, week 52)
- Change in FPG From Baseline to Week 52(Week 0, week 52)