Pharmacokinetic and pharmacodynamic profile of rapid-acting insulin injected by needle-free jet-injectio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

Inclusion criteria for healthy subjects
• Age 18-50 years
• Body-mass index 18-28 kg/m2
• Blood pressure <160/90 mmHg
Inclusion criteria for patients with type 1 diabetes
• Age 18-50 years
• Body-mass index 18-28 kg/m2
• Stable glycaemic control with HbA1c 6.5-9.0%
• Duration of diabetes >1 year
• Blood pressure <160/90 mmHg

Exclusion Criteria

Exclusion criteria for healthy subjects
• 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)
• Type 2 diabetes in first-degree relatives
• History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
• Pregnancy
Exclusion criteria for patients with type 1 diabetes
• Inability to provide informed consent
• Chronic use of medication other than insulin, oral contraceptives, thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months), or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment
• Macroalbuminuria, i.e. urinary albumin excretion >200 *g/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample
• Symptomatic diabetic neuropathy
• Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion)
• History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
• Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic parameters: maximal exogenous glucose infusion rate (GIR Cmax)<br /><br>and time to maximal GIR (GIR Tmax) to maintain euglycaemia, area under the GIR<br /><br>curve, and time to median GIR (TAUC*). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic parameters: maximal insulin concentration (Cmax) and time to<br /><br>maximal insulin concentration (Tmax) after insulin injection, and area under<br /><br>the insulin concentration curve (AUC). </p><br>