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

Nanjing First Hospital, Nanjing Medical University0 sites60 target enrollmentSeptember 12, 2019

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Nanjing First Hospital, Nanjing Medical University
Enrollment: 60
Primary Endpoint: Blood glucose profile
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 12, 2019

End Date

October 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Nanjing First Hospital, Nanjing Medical University

Responsible Party

Sponsor

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.