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CompletedNCT04074603Updated Oct 27, 2022

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

An interventional study of The needle-free jet injector and Conventional insulin pen in Type 2 Diabetes, sponsored by Jian-hua Ma. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Jian-hua Ma · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To comparing 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 and safety in type 2 diabetic patients.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Needle-free jet injection
  • Insulin glargine
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 150 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

This is the only study on the registry with Jian-hua Ma as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
150 participants (actual)

Study arms

  • Experimental
    Group A

    needle-free before needle

    Device: The needle-free jet injector

  • Experimental
    Group B

    needlebefore needle-free

    Device: Conventional insulin pen

Interventions

  • DeviceThe needle-free jet injector

    Continuous insulin therapy for 2 weeks

  • DeviceConventional insulin pen

    Continuous insulin therapy for 2 weeks

06

What researchers measure

Primary outcomes

  1. Blood glucose changes

    The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on blood glucose changes in T2Dm

    Time frame: 2 weeks

  2. 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.

    Time frame: 2 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 weeks

07

Study locations

1 site
  • Nanjing First Hospital
    Nanjing, Jiangsu 210006, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Dec 2020, 15 months.

Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 15 months is below that.

Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2019
First posted
Aug 30, 2019
StartActual
Sep 1, 2019
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2021
Last update
Oct 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04074603
Lead sponsor
Jian-hua Ma
Responsible party
Jian-hua Ma (Director, Head of Endocrinology department, Clinical Professor, Nanjing First Hospital, Nanjing Medical University) — Sponsor-investigator
First posted
Aug 30, 2019
Start date
Sep 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021
Last update
Oct 27, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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