Status:
COMPLETED
Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose
Lead Sponsor:
Beijing QS Medical Technology Co., Ltd.
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In this study, QS-M needle-free injector and needle-insulin pen were used as a drug carrier to control blood glucose in type 2 diabetic patients（T2DM）.The efficacy and safety of QS-M needle-free injec...
Detailed Description
The research purpose is to evaluate the efficacy and safety of QS-M needle-free injector as a drug carrier in the control of blood glucose in patients with type 2 diabetes mellitus by non-inferiority ...
Eligibility Criteria
Inclusion
- have been diagnosed with type 2 diabetes; (A) have been treated with insulin (premixed or basal) subcutaneous injection therapy (without limitation or combined oral hypoglycemic agents); (B) the subjects with poor blood sugar control is taking oral hypoglycemic agents or living interventions need Initiating insulin therapy (see Appendix 1 for initiating treatment regimens);
- adults aged 18-75 years, women of childbearing age need to take adequate contraceptive measures to reduce the pregnancy risk to the minimum;
- injection of insulin and / or oral hypoglycemic agents ≥ 3 months before enroll the study, the insulin dose adjustment ≤ 10% within 1 month before enrolling (adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
- have a HbAlc value (detected by NGSP approved method) between 7.5-11% ;
- BMI ≤ 32kg / m2, the body weight remained relatively stable, body weight change of no more than 10% at least 3 months before screening,
- Male subjects hemoglobin≥12g/dl (≥ 120g / L), female subjects hemoglobin ≥ 11g / dl (≥ 110g / L);
- serum creatinine \<1.5 mg / dL for male subjects, serum creatinine \<1.4 mg / dL for female subjects;
- have not participated in other clinical studies related diabetes treatment within 3 months ;
- be volunteered to participate in this clinical study and signed informed consent.
Exclusion
- the persons who attend or perform this study;
- women in pregnancy or lactation;
- have frequent severe hypoglycaemia in one month; have blood glucose control adverse events like diabetic ketoacidosis or hyperosmotic diabetic coma within half a year;
- have severe cardiovascular events in the past 6 months, such as myocardial infarction, acute coronary syndrome, cerebral infarction, cardiovascular and cerebrovascular surgery;
- have used hormones or immunosuppressive agents, or have immunologic deficiency disease;
- have end-stage renal disease, and are receiving dialysis treatment;
- have of history of cancer within 5 years;
- have history of severe mental instability;
- have long-term alcohol abuse or drug abuse history;
- have Skin lesions in the insulin injection site;
- have history of anemia caused by hemoglobinopathy (such as sickle cell red blood cell anemia, thalassemia, sideroblastic anemia) or any other course;
- have critically ill, or life expectancy is less than one year;
- difficult to evaluate the effectiveness and safety of the device intervention;
- have a clear infection history within a month, such as pneumonia;
- have active liver disease (AST\> 3 times of normal upper limit or ALT\> 3 times of normal upper limit);
- have history of acute pancreatitis within a month;
- have history of insulin allergy;
- have been expected to have poor compliance and can not be treated according to the research protocol;
- other cases that investigators believe that the subject may fail to complete the study or may have a significant impact.
Key Trial Info
Start Date :
August 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2018
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT03243903
Start Date
August 18 2017
End Date
November 8 2018
Last Update
March 27 2020
Active Locations (1)
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1
Peking University People 's Hospital
Beijing, Beijing Municipality, China, 10000