NCT02906917已完成3 期
This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.
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
- 532
- 试验地点
- 1
- 主要终点
- Change in HbA1c (%) - Week 26
研究概览
简要总结
Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.
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
- •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 at least 18 years at the time of signing informed consent Algeria: Male or female, age at least 19 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus
- •Treated with any basal insulin for at least 90 days prior to the day of screening
- •Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin at least 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (at least half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v. Oral combination products (of the allowed individual OADs above)
- •HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
- •Body mass index (BMI) equal to or below 45.0 kg/m^2
排除标准
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (V1)
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
- •Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal or below 90 days prior to the day of the screening and between screening and randomisation
- •Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening
- •Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at 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
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
- •Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
研究组 & 干预措施
IDegAsp
Experimental
干预措施: Insulin degludec/insulin aspart (Drug)
IGlar + IAsp
Active Comparator
干预措施: Insulin glargine (Drug)
IGlar + IAsp
Active Comparator
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Change in HbA1c (%) - Week 26
时间窗: Week 0, week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.
次要结局
- Responder (Yes/No) for HbA1c < 7%(Week 26 and week 38)
- Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia(Week 26 and week 38)
- Change in FPG(Week 0, week 26, week 38)
- Change in Pre-breakfast SMPG (Used for Titration)(Week 1, week 26, week 38)
- Change in Postprandial SMPG Increment (From 9-point Profile)(Week 0, week 26, week 38)
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26, weeks 16-26, weeks 0-38)
- Change in HbA1c (%) - Week 38(Week 0, week 38)
- Total Insulin Dose(Week 26 and week 38)
- Incidence of TEAEs(Weeks 0-26, weeks 26-38, weeks 0-38)
- Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26, weeks 16-26, weeks 0-38)
- Change in Body Weight(Week 0, week 26, week 38)
研究者
研究点 (1)
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