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

NCT ID: NCT04093284

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2019-10-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

The needle-free jet injector

Intervention Type: DEVICE

Continuous insulin therapy for 9 days

Group B

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

Group Type: EXPERIMENTAL

The needle-free jet injector

Intervention Type: DEVICE

Continuous insulin therapy for 9 days

Interventions

The needle-free jet injector

Continuous insulin therapy for 9 days

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jianhua Ma

Role: CONTACT

majianhua196503@126.com

+8618951670116 ext. +8618951670116

References

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.

Reference Type: DERIVED

PMID: 33317342 (View on PubMed)

Other Identifiers

KY20190823-01

Identifier Type: -

Identifier Source: org_study_id