Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The needle-free jet injector
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Needle-free jet injection, Insulin glargine, Flash Glucose Monitoring
Eligibility Criteria
Inclusion Criteria:
- volunteer to participate and be able to sign informed consent prior to the trial.
- patients with type 2 diabetes, aged 18-65 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (12-18 units) combined with oral medicationis, stable for more than 2 months.
- No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Exclusion Criteria:
- Patients with insulin allergy.
- Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- Drug abuse and alcohol dependence in the past 5 years.
- Systemic hormone therapy was used in the last three months.
- Patients with poor compliance and irregular diet and exercise.
- Patients with pregnancy, lactation or pregnancy intention.
- Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days
The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days
Outcomes
Primary Outcome Measures
Blood glucose profile
changes of blood glucose profile
Secondary Outcome Measures
Sensitivity Questionnaire of Patients
changes of Sensitivity Questionnaire of Patients
Full Information
NCT ID
NCT04093284
First Posted
September 16, 2019
Last Updated
September 16, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04093284
Brief Title
Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
Official Title
Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2019 (Anticipated)
Primary Completion Date
October 20, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen
Detailed Description
Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile of CGMS and safety in type 2 diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Needle-free jet injection, Insulin glargine, Flash Glucose Monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days
Arm Title
Group B
Arm Type
Experimental
Arm Description
The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days
Intervention Type
Device
Intervention Name(s)
The needle-free jet injector
Intervention Description
Continuous insulin therapy for 9 days
Primary Outcome Measure Information:
Title
Blood glucose profile
Description
changes of blood glucose profile
Time Frame
9 days
Secondary Outcome Measure Information:
Title
Sensitivity Questionnaire of Patients
Description
changes of Sensitivity Questionnaire of Patients
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
volunteer to participate and be able to sign informed consent prior to the trial.
patients with type 2 diabetes, aged 18-65 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (12-18 units) combined with oral medicationis, stable for more than 2 months.
No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Exclusion Criteria:
Patients with insulin allergy.
Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
Drug abuse and alcohol dependence in the past 5 years.
Systemic hormone therapy was used in the last three months.
Patients with poor compliance and irregular diet and exercise.
Patients with pregnancy, lactation or pregnancy intention.
Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Ma
Phone
+8618951670116
Ext
+8618951670116
Email
majianhua196503@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33317342
Citation
Kong X, Luo M, Cai L, Zhang P, Yan R, Hu Y, Li H, Ma J. Needle-free jet injection of insulin glargine improves glycemic control in patients with type 2 diabetes mellitus: a study based on the flash glucose monitoring system. Expert Opin Drug Deliv. 2021 May;18(5):635-641. doi: 10.1080/17425247.2021.1863945. Epub 2021 Feb 19.
Results Reference
derived
Learn more about this trial
Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
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