Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen

Type 2 Diabetes Clinical Trial

Official title:

Comparing the Effects of Insulin Glargine on Peripheral Blood Glucose Between Needle-free Jet Injection and Conventional Insulin Pen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074603
• Other study ID #: KY20190530-02-KS-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To comparing 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 and safety in type 2 diabetic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• volunteer to participate and be able to sign informed consent prior to the trial.

• patients with type 2 diabetes, aged 18-80 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (4-35 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

• Type 2 Diabetes

Intervention

Device:
• The needle-free jet injector
Continuous insulin therapy for 2 weeks
• Conventional insulin pen
Continuous insulin therapy for 2 weeks

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jian-hua Ma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose changes	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on blood glucose changes in T2Dm	2 weeks
Primary	The glucose fluctuation	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on glucose profile (MAGE, 24h-MG, CV%, SDBG, TAR, TIR, TBR) changes in type 2 diabetes mellitus by FGM.	2 weeks
Secondary	Assessment of safety and tolerance	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on safety and tolerance changes in type 2 diabetes mellitus by Questionnaire.	2 weeks