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

Phase 1

• Conditions: type 1 diabetes mellitus; MedDRA version: 12.0Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2009-015398-11-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-16
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified