CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
jet injection devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01438632
NCT01438632Phase 4Completed

Pharmacology of Rapid-acting Insulin Injected by Needle-free Jet-injection in Patients With Diabetes

Radboud University Medical Center·interventional·Posted Sep 22, 2011·Updated Mar 12, 2013

In Brief

A Phase 4 clinical trial evaluating jet injection device for Diabetes Mellitus. Completed, enrolled 24 participants across 1 site.

Detailed Summary

A previous study showed that absorption and glucose-lowering action of rapid-acting insulin analogues occurred twice as fast when these analogues were administered by jet injection technology rather than by conventional insulin pen in healthy non-diabetic subjects. This study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with jet-injection or a conventional insulin pen prior to a standardised meal in patients with diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2011
Enrollment StartSep 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.8 years ago

Interventions

jet injection devicedevice

Rapid-acting insulin analogue aspart (Novorapid®) administration by means of a jet injector or a conventional insulin pen in the subcutaneous tissue. Dosage of insulin will be determined by the normal dosage of insulin used by the patient before breakfast.