A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Elaine Chow
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Glycemic variability
研究概览
简要总结
This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with insulin glargine U300/ml insulin versus conventional (NPH) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited. They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks. All subjects will follow a insulin-self titration algorithm. The study will consist of 9 visits over 26 weeks. Blood glucose variability will be collected by CGM for 7 consecutive days at baseline (week -1) and at week 24.Secondary endpoints other than data on glycemic variability, including HbA1c, fasting plasma glucose, inflammatory markers will be measured during three periods (week 0, week 12 and week 24).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment
- •18 ≤ age ≤ 75
- •Stable dose of oral antidiabetic treatment for > 8 weeks
- •The number of OADs that the patients used should be "3" or less
- •HbA1c level > 7.0% and < 10%
- •Fasting plasma glucose > 8mmol/L and <15mmol
- •BMI < 40 kg/m2
- •Patient who is capable and willing to perform regular SMBG
- •Patient who is capable and willing for insulin injection
- •Confirmed written consent
- •Insulin naïve
排除标准
- •Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry
- •Patient known to have hypoglycaemia unawareness or recurrent major hypoglycaemia
- •Any product containing prandial insulin
- •Concomitant medication known to interface with glucose metabolism (such as systematic steroids)
- •Change in dose of non-insulin anti-diabetic treatment or initiation of new anti-diabetic medications in the last 8 weeks prior to screening
- •Patients treated with steroid or nonsteroidal anti-inflammatory drugs
- •Patient who had experienced an acute concurrent illness during the 3-month period before the investigation
- •Patient with hepatic disease and end-stage renal disease
- •Patients unable to comply with follow-up visits
- •Pregnant or breastfeeding women
研究组 & 干预措施
Active
Insulin glargine 300U/ml
干预措施: Insulin Glargine 300 UNT/ML (Drug)
Control
Neutral Protamine Hagedorn insulin
干预措施: Neutral protamine hagedorn insulin (Drug)
结局指标
主要结局
Glycemic variability
时间窗: 24 weeks
Standard deviation of glucose from continuous glucose monitoring
次要结局
- Inflammatory markers(24 weeks)
- Glycemic variability(24 weeks)
- Incidence of hypoglycemia(24 weeks)
- Percentage time in target(24 weeks)
- Fasting blood glucose(24 weeks)
- Proportion of patients achieving HbA1c <7.0%(24 weeks)
- Heart rate variability(24 weeks)
- Glycated haemoglobin(24 weeks)
- Treatment satisfaction(24 weeks)
研究者
Elaine Chow
Dr, Clinical Lecturer
Chinese University of Hong Kong