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

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

To comparing the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: The needle-free jet injector; Device: 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 and safety in type 2 diabetic patients.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; needle-free before needle	Device: The needle-free jet injector; Continuous insulin therapy for 2 weeks
Experimental: Group B; needlebefore needle-free	Device: Conventional insulin pen; Continuous insulin therapy for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose changes	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on blood glucose changes in T2Dm	2 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jian-hua Ma

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Insulin glargine; Needle-free jet injection
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: KY20190530-02-KS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No