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Reliability of Insulin by Jet Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272296
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Using a specific jet injector for the administration of a rapid-acting insulin analogue has been shown to advance the absorption of insulin from the subcutaneous area into the bloodstream by 40-50%, when compared to conventional injection by insulin pens. The reproducibility of the jet stream method has not been previously determined in vivo. It is also unknown how the efficacy of injecting regular insulin by jet stream compares to that of rapid-acting analogues injected by conventional pen.

Objectives: 1. To compare the pharmacologic reproducibility of the rapid-acting insulin analogue aspart (Novorapid®) injected by jet-injection to that of the same insulin injected with a conventional pen. 2. To compare pharmacokinetic and -dynamic profile of regular insulin injected by jet injection to that of aspart insulin injected by conventional pen.

Study design: Double-blind double-dummy randomized controlled parallel/cross-over


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: jet injector Device: Conventional pen (NovoPen IV) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reproducibility of Insulin Action When Administered by Needle-free Jet Injection
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Jet Injector_main study
Administration of insulin or placebo injection in main study
Device: jet injector
1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
Other Name: Insujet™, European Pharma Group, The Netherlands

Device: Conventional pen (NovoPen IV)
1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
Other Name: NovoPen IV, Novo Nordisk

Placebo Comparator: conventional pen, NovoPen IV
Administration of insulin or placebo injection in main study
Device: jet injector
1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
Other Name: Insujet™, European Pharma Group, The Netherlands

Device: Conventional pen (NovoPen IV)
1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
Other Name: NovoPen IV, Novo Nordisk

Active Comparator: jet injector_sub study
Administration of insulin or placebo injection in sub study
Device: jet injector
1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
Other Name: Insujet™, European Pharma Group, The Netherlands




Primary Outcome Measures :
  1. (TmaxGIR) [ Time Frame: 0-6 hrs ]
    The variability in time until maximal glucose lowering effect, as determined by exogenous glucose requirement (TmaxGIR) to maintain normoglycemia, after insulin injection. Primary endpoint of main study

  2. Tmax (min) [ Time Frame: 0-6 hrs ]
    Time to maximal exogenous glucose infusion rate (GIR, in ml/min/kg) required to maintain euglycaemia. Primary endpoint of sub study.


Secondary Outcome Measures :
  1. CmaxGIR (mg/min) [ Time Frame: 0-6 hrs ]
    Maximal GIR during the 6-hour study (from timepoint 0)

  2. CmaxINS (pmol/l) [ Time Frame: 0-6 hrs ]
    Maximal insulin concentration during the 6-hour study (from timepoint 0)

  3. TmaxINS (min) [ Time Frame: 0-6 hrs ]
    Time to maximal insulin concentration (Cmax)

  4. AUCINS (pmol/min/l) [ Time Frame: 0-6 hrs ]
    area under the insulin concentration curve during the 6-hour study

  5. AUCGIR (g): [ Time Frame: 0-6 hrs ]
    Area under the GIR curve during the 6-hour study (from timepoint 0)

  6. T-GIRAUC50% (min) [ Time Frame: 0-6 hrs ]
    Time of 50% of glucose disposal, i.e. the median of the GIR profile

  7. T-INSAUC50% (min) [ Time Frame: 0-6 hrs ]
    Time until 50% of insulin absorption (mean residence time, MRT)


Other Outcome Measures:
  1. Tolerability [ Time Frame: at second test day, at timepoint 0, for 5 minutes, ]
    The amount of discomfort or pain with the two administration methods using a numeric rating scale from 0 to 10 (VAS-score)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Age 18-50 years
  • Body-Mass Index 18-32 kg/m2
  • Blood pressure <160/90 mmHg

Exclusion criteria

  • Inability to provide informed consent
  • Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
  • Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
  • Known allergy to aspart insulin
  • History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
  • Presence of any other medical condition that might interfere with the study protocol
  • Pregnancy or the intention to become pregnant
  • Anemia, defined as an Hb of <8.1 mmol/l for male subjects and <7.5 for female subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272296


Locations
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Netherlands
Radboud university medical center
Nijmegen, Netherlands, 6542 JK
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Bastiaan E de Galan, MD, PhD Radboud University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02272296    
Other Study ID Numbers: PKPD_INSJ_4
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Radboud University:
Injections, Jet
pharmacology
Insulin Aspart
Equipment and Supplies
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs