Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093284
• Other study ID #: KY20190823-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: September 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jianhua Ma
• Phone: +8618951670116
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• The needle-free jet injector
Continuous insulin therapy for 9 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose profile	changes of blood glucose profile	9 days
Secondary	Sensitivity Questionnaire of Patients	changes of Sensitivity Questionnaire of Patients	9 days