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Status unknownNCT04093284Updated Sep 18, 2019

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

An interventional study of The needle-free jet injector in Diabetes Mellitus, Type 2, sponsored by Nanjing First Hospital, Nanjing Medical University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Needle-free jet injection
  • Insulin glargine
  • Flash Glucose Monitoring
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group A

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

    Device: The needle-free jet injector

  • Experimental
    Group B

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

    Device: The needle-free jet injector

Interventions

  • DeviceThe needle-free jet injector

    Continuous insulin therapy for 9 days

06

What researchers measure

Primary outcomes

  1. Blood glucose profile

    changes of blood glucose profile

    Time frame: 9 days

Secondary outcomes

  1. Sensitivity Questionnaire of Patients

    changes of Sensitivity Questionnaire of Patients

    Time frame: 9 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 33317342 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04093284
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
Sep 18, 2019
Start date
Sep 12, 2019 (estimated)
Primary completion
Oct 20, 2019 (estimated)
Completion
Oct 30, 2019 (estimated)
Last update
Sep 18, 2019

Study contacts

Jianhua Ma
Contact
majianhua196503@126.com
+8618951670116 ext. +8618951670116

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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