NCT03420040Unknown不适用
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年11月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in fasting blood glucose between baseline to week 4
研究概览
简要总结
A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China was carried out. The two kinds of injection methods were evaluated as subcutaneous injection of insulin glargine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female aged 18-70 years of age, women of childbearing age need to take adequate contraceptive measures to minimize the risk of pregnancy;
- •the standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year;
- •18 Kg/m2 = BMI = 30Kg/m2;
- •received daily injections of insulin glargine and also take one to three kinds of oral medicine (not including secretagogues) patients, daily insulin glargine total dose more than 12IU but <50IU, the use of insulin glargine than in January;
- •the blood glucose in the fasting vein was in 5.0-9.0mmol/L;
- •the letter of informed consent has been read and signed.
排除标准
- •there is conflict of interest with this research.
- •blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma.
- •serious diabetic complications such as diabetic foot, diabetic nephropathy and so on;
- •severe cardiovascular events occurred in the last 6 months.
- •the application of hormone or immunosuppressant, or low immunity defect;
- •the use of non steroidal anti-inflammatory drugs;
- •the use of sulfonylureas and insulin secreting agents;
- •a person with a history of cancer;
- •a history of unstable or rapid progressive renal disease;
- •an unstable history of major mental illness;
- •the history of hemoglobin (such as sickle red cell anemia, thalassemia, iron granulocytic anemia);
- •women who are pregnant or are breastfeeding;
- •in the near future there is a clear infection, such as urinary tract infection and pneumonia;
- •recent important visceral hemorrhage, such as gastric hemorrhage and cerebral hemorrhage, etc.
- •skin diseases such as exfoliative dermatitis, pustular sore and infection of pyogenic bacteria;
- •the history of acute pancreatitis or pancreatectomy;
- •the researchers believe that it may lead to any situation in which the subject is unable to complete the study or may cause significant risk to the subject.
- •the results of the laboratory examination are as follows: A. obvious abnormal liver function or in the active phase of the disease (AST> 3 times the upper limit of normal ALT> or 3 times the upper limit of normal); The creatinine clearance rate of B. was <60ml/min; C. anaemia caused by any cause of the disease; The results of pregnancy test in women of childbearing age of D. were positive.
研究组 & 干预措施
QS-M Needle Free Injector group
Experimental
To observe the use of insulin in glycemia under good blood glucose control in the QS-M Needle Free Injector group.
干预措施: QS-M Needle Free Injector (Device)
Glargine pen group
Active Comparator
To observe the amount of insulin used by the Glargine pen group under good blood glucose control.
干预措施: Glargine pen (Device)
结局指标
主要结局
Change in fasting blood glucose between baseline to week 4
时间窗: baseline and week 4
fasting blood glucose are measured at baseline and week 4
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes MellitusType1 DiabetesNCT01838083Sanofi50
已完成
1 期
Characteristics of Glargine in Type 2 DiabeticsType 2 DiabetesNCT00574912Vanderbilt University Medical Center20
已完成
不适用
Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin PenType 2 DiabetesNCT04074603Jian-hua Ma150
Unknown
不适用
Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet SyringeDiabetes Mellitus, Type 2NCT04093284Nanjing First Hospital, Nanjing Medical University60
已完成
3 期
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)Diabetes Mellitus, Type 2NCT01191268Eli Lilly and Company884