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

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

Sponsors

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Source Nanjing First Hospital, Nanjing Medical University
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.

Overall Status Not yet recruiting
Start Date September 12, 2019
Completion Date October 30, 2019
Primary Completion Date October 20, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Blood glucose profile 9 days
Secondary Outcome
Measure Time Frame
Sensitivity Questionnaire of Patients 9 days
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: The needle-free jet injector

Description: Continuous insulin therapy for 9 days

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Contact

Last Name: Jianhua Ma

Phone: +8618951670116

Phone Ext.: +8618951670116

Email: [email protected]

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group A

Type: Experimental

Description: The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days

Label: Group B

Type: Experimental

Description: The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov