NCT01880736已完成3 期
A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated 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
- 458
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
- •Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
- •HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
- •Body mass index (BMI) equal to or below 35 kg/m^2
排除标准
- •Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
- •Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)
- •Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
- •Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
- •Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
研究组 & 干预措施
IDeg OD Flexible Dose
Experimental
干预措施: insulin degludec (Drug)
IDeg OD Fixed Dose
Experimental
干预措施: insulin degludec (Drug)
IDeg OD Simple
Experimental
干预措施: insulin degludec (Drug)
IDeg OD Stepwise
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
时间窗: Week 0, week 26
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Weeks 0-26)
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))(Weeks 0-26)
- Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes(Weeks 0-26)
- Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period(From week 16 to end of trial (week 27))
- Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial(After 26 weeks of treatment)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition(Weeks 0-26)
- Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period(From Week 16 to end of trial (week 27))
研究者
研究点 (1)
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