Status:
UNKNOWN
Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Needle-free Injector
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In this prospective, multi-center, randomized, open-label, parallel group trial, the safety and efficacy of needle-free injector will be compared with insulin pen after 2 weeks of treatment in patient...
Detailed Description
The objective of the current study is to investigate the efficacy, safety and tolerability of needle-free injector compared to conventional insulin pen given for 2 weeks as the insulin carrier in pati...
Eligibility Criteria
Inclusion
- Patients ≥ 18 and ≤75 years with type 2 diabetes;
- HbA1c ≥ 7.5 to ≤11.0%;
- Receipt of premixed insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study, and insulin dose adjustments ≤ 10% within 4 weeks before enrollment (dose adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
- BMI ≤ 32kg / m2.
Exclusion
- Patients with any of the following conditions will be excluded:
- Pregnant or lactating women
- Severe hypoglycemia within one month; diabetic ketoacidosis or hyperosmotic diabetic status within 6 months prior to informed consent
- Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
- Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
- Severe mental instability, or alcohol abuse, or drug abuse
- Skin lesions at the insulin injection site
- Cancer within 5 years prior to informed consent
- Pancreatitis of severe infectious diseases within 1 months prior to informed consent
- Known hypersensitivity or allergy to the insulin
- Renal impairment (CKD-EPI eGFR\<60ml/min)
- Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
- Participation in another trial within 2 months prior to informed consent
- Patients that investigators believe may fail to complete the study
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04682795
Start Date
September 1 2021
End Date
December 31 2022
Last Update
September 1 2021
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
Changxing, Zhejiang, China
2
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China, 310000
3
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
4
Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China