The Differences Between Insulin Glargine U300 and Insulin Degludec U100 in Impact on the Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles in Insulin naïve Patients Suffering From Type Two Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes from baseline in glucose variability
研究概览
简要总结
To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with DMT2.
详细描述
We recruited a total of 25 patients (23 completed the study) with T2DM who had uncontrolled disease on two or more oral antidiabetic drugs. After the wash-up period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was applied for 12 weeks. At the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed and augmentation index was measured. On three consecutive days prior to each control point, patients performed a 7-point SMBG profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (d-ROM) in serum. For augmentation index measuring, we used SphygmoCor (AtCor Medical, Sydney, Australia) which allow non-invasive measurement of AIx on radial artery using strain gauge transducer placed on the tip of a pencil-type tonometer. This method is based on the principle of applanation tonometry
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of DMT2 for at least 1 year
- •aged between 18 and 65 years (women obligatory postmenopausal)
- •uncontrolled glycaemia on two or more oral antidiabetic drugs
- •no prior use of insulin
- •HbA1c ≥7.5%
- •receiving statins (if not on statins, they were put on it)
- •not on antiaggregant therapy (if on antiaggregants, they were temporarily excluded from therapy)
- •Exclusion criteria:
- •the presence of malignant disease
- •chronic liver disease
- •renal impairment with creatinine clearance < 60 ml/s
- •severe cardiovascular disease or history of cardiovascular incidents (stroke, myocardial infarction, peripheral amputation)
- •rheumatic and autoimmune diseases and the usage of glitazones or anticoagulant therapy
排除标准
- 未提供
研究组 & 干预措施
degludec arm
25 patients were discontinued their previous therapy and given metformin alone (2 g/day) for seven days. After seven days they were randomized to first receive IDeg-100 In phase one they received IDeg-100 and metformin for 12 weeks. Phase one was followed by a second wash-up period in which patients received metformin alone again for seven days. In phase two, which also lasted for 12 weeks, patients were switched from IDeg-100 to IGlar-300 (and metformin was continued). The initial dose of both insulins was 0.2 IU/kg.
干预措施: Degludec (Drug)
glargine arm
25 patients were discontinued their previous therapy and given metformin alone (2 g/day) for seven days. After seven days they were randomized to first receive IGlar-300 In phase one they received IGlar-300 and metformin for 12 weeks. Phase one was followed by a second wash-up period in which patients received metformin alone again for seven days. In phase two, which also lasted for 12 weeks, patients were switched from IGlar-300 to IDeg-100 (and metformin was continued). The initial dose of both insulins was 0.2 IU/kg.
干预措施: Glargine U300 (Drug)
结局指标
主要结局
Changes from baseline in glucose variability
时间窗: 3 months
Glucose variability will be assessed at the beginning and the end of each phase using 3-day 7-point SMBG and calculating coefficient of variation in % out of SMBG recordings
Changes from baseline in oxidative stress
时间窗: 3 months
Oxidative stress will be assessed at the beginning and the end of each phase by measuring thiol groups and hydroperoxides (d-ROM) in serum
Changes from baseline in arterial stiffness after treatment
时间窗: 3 months
Oxidative stress will be assessed at the beginning and the end of each phase by measuring augmentation index with SphygmoCor.
次要结局
- Changes from baseline in LDH(3 months)
- Changes from baseline in hematocrit(3 months)
- Changes from baseline in total cholesterol(3 months)
- Changes from baseline in LDL(3 months)
- Changes from baseline in platelets(3 months)
- Changes from baseline in WBC(3 months)
- Changes from baseline in RBC(3 months)
- Changes from baseline in MCV(3 months)
- Changes from baseline in ALP(3 months)
- Changes from baseline in hemoglobin(3 months)
- Changes from baseline in CRP(3 months)
- Changes from baseline in triglycerides(3 months)
- Changes from baseline in HDL(3 months)
- Changes from baseline in liver enzymes(3 months)
研究者
Mladen Krnic
Assistant professor
University of Split, School of Medicine