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NCT Number: NCT00983775

Pharmacology of Insulin Injected With Jet-Injection

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, P.O. Box 9101, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

jet injector (SQ pen/Novopen III)

Device

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

Primary outcomes

  1. (time to) maximal glucose infusion rate

    Time frame: 0-8 hours after insulin injection

Secondary outcomes

  1. (time to) maximal insulin concentration

    Time frame: 0-8 hours after insulin injection

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 24, 2009
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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