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

NCT04074603 | Completed

• 1 other identifier: KY20190530-02-KS-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

Needle-free jet injection; Insulin glargine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of safety and tolerance

  2 weeks

Study Arms (2)

Group A

EXPERIMENTAL

needle-free before needle

Device: The needle-free jet injector

Group B

EXPERIMENTAL

needlebefore needle-free

Device: Conventional insulin pen

Interventions

The needle-free jet injector DEVICE

Continuous insulin therapy for 2 weeks

Group A

Conventional insulin pen DEVICE

Continuous insulin therapy for 2 weeks

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian-hua Ma: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Endocrinology department, Clinical Professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

CN (1)