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Pharmacology of Insulin Injected With 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: NCT00983775
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
Radboud University

Brief Summary:
The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: jet injector (SQ pen/Novopen III) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection
Study Start Date : November 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: healthy low dose insulin
16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight.
Device: jet injector (SQ pen/Novopen III)
The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
Other Names:
  • SQ pen
  • Novopen III

Experimental: healthy high dose insulin
16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.
Device: jet injector (SQ pen/Novopen III)
The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
Other Names:
  • SQ pen
  • Novopen III

Experimental: type 1 diabetes mellitus
16 people with type 1 diabetes mellitus. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.
Device: jet injector (SQ pen/Novopen III)
The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
Other Names:
  • SQ pen
  • Novopen III




Primary Outcome Measures :
  1. (time to) maximal glucose infusion rate [ Time Frame: 0-8 hours after insulin injection ]

Secondary Outcome Measures :
  1. (time to) maximal insulin concentration [ Time Frame: 0-8 hours after insulin injection ]


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 18-28 kg/m2
  • Blood pressure <160/90 mmHg
  • Stable glycaemic control with HbA1c 6.5-9.0% (for patients with type 1 diabetes mellitus)
  • Duration of diabetes >1 year (for patients with type 1 diabetes mellitus)

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)
  • Chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment (for patients with type 1 diabetes mellitus)
  • Type 2 diabetes in first-degree relatives (for healthy subjects)
  • History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
  • Pregnancy
  • Macroalbuminuria, i.e. urinary albumin excretion >200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus)
  • Symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus)
  • Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)

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): NCT00983775


Locations
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Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, P.O. Box 9101, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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Study Chair: Cees J Tack, MD PhD Radboud University
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Responsible Party: Cees Tack, MD PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00983775    
Other Study ID Numbers: PKPD_SQ_1
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: September 2009
Keywords provided by Radboud University:
Pharmacokinetic profile
Pharmacodynamic profile
insulin
jet injector
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases