Pharmacology of Insulin Injected With Jet-Injection

Radboud University Medical Center48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

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.

jet injector (SQ pen/Novopen III)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, P.O. Box 9101, Netherlands

Outcomes

Primary Outcomes

(time to) maximal glucose infusion rate

Time frame: 0-8 hours after insulin injection

Secondary Outcomes

(time to) maximal insulin concentration

Time frame: 0-8 hours after insulin injection

Data from ClinicalTrials.gov

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