Status:
UNKNOWN
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
Lead Sponsor:
Xijing Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 gl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03420040
Start Date
November 27 2017
End Date
April 1 2018
Last Update
February 5 2018
Active Locations (1)
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1
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, China, 710032