Clinical trial NCT03420040: A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
Official title: A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Glargine Insulin
QS-M Needle Free Injector
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 glargine.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. the standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year;
3. 18 Kg/m2 = BMI = 30Kg/m2;
4. 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;
5. the blood glucose in the fasting vein was in 5.0-9.0mmol/L;
6. the letter of informed consent has been read and signed.

Exclusion Criteria:

1. there is conflict of interest with this research.
2. blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma.
3. serious diabetic complications such as diabetic foot, diabetic nephropathy and so on;
4. severe cardiovascular events occurred in the last 6 months.
5. the application of hormone or immunosuppressant, or low immunity defect;
6. the use of non steroidal anti-inflammatory drugs;
7. the use of sulfonylureas and insulin secreting agents;
8. a person with a history of cancer;
9. a history of unstable or rapid progressive renal disease;
10. an unstable history of major mental illness;
11. the history of hemoglobin (such as sickle red cell anemia, thalassemia, iron granulocytic anemia);
12. women who are pregnant or are breastfeeding;
13. in the near future there is a clear infection, such as urinary tract infection and pneumonia;
14. recent important visceral hemorrhage, such as gastric hemorrhage and cerebral hemorrhage, etc.
15. skin diseases such as exfoliative dermatitis, pustular sore and infection of pyogenic bacteria;
16. the history of acute pancreatitis or pancreatectomy;
17. 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.
18. 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.

Primary outcomes:
measure: Change in fasting blood glucose between baseline to week 4
timeFrame: baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical university
state: Shaanxi
Study officials:
affiliation: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
name: Qiuhe Ph.D Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xing Y, Xie X, Xu J, Liu J, He Q, Yang W, Zhang N, Li X, Wang L, Fu J, Zhou J, Gao B, Ming J, Liu X, Lai J, Liu T, Shi M, Ji Q. Efficacy and safety of a needle-free injector in Chinese patients with type 2 diabetes mellitus treated with basal insulin: a multicentre, prospective, randomised, crossover study. Expert Opin Drug Deliv. 2019 Sep;16(9):995-1002. doi: 10.1080/17425247.2019.1649251. Epub 2019 Aug 5.