Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
Information source: Becton, Dickinson and Company
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: regular insulin (Humulin) (Drug); Insulin lispro (Humalog) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Becton, Dickinson and Company Official(s) and/or principal investigator(s):
Christoph Kapitza, MD, Principal Investigator, Affiliation: Profil Institut fur Stoffwechselforschung GmbH
Overall contact:
Christoph Kapitza, MD, Phone: 49 2131/4018-157, Email: Christoph.Kapitza@profil-research.de
Summary
This study is to determine the effect of intra-dermal (ID) administration of regular and of
rapid-acting insulin, before eating, on blood glucose levels for several hours after a
standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously,
for control or comparison purposes. The hypothesis or expectation is that ID insulin will
work more quickly and control blood glucose levels better than SC injection.
Clinical Details
Official title: A Mono Center Open Labeled, Randomized Study Examining the Effects of Intra-Dermal vs Subcutaneous Application of Regular Insulin or Rapid Acting Insulin Analogue on Postprandial Glycemic Excursions in Patients With Type 1 Diabetes
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
Secondary outcome: • Maximal BG (BGmax)
• time to BGmax (tBGmax)
• total BG-AUC0-4 h
• Minimal BG (BGmin)
• time to BGmin (tBGmin)
• Insulin pharmacokinetics
• Number and seriousness of adverse events
• Vital signs, examination of insulin application
Detailed description:
Previous studies have shown that intra-dermal (ID) insulin administration results in a more
rapid onset of action in comparison to subcutaneous (SC) administration as measured by
glucose infusion rate (GIR) under glucose clamp conditions. The aim of this study is to
investigate whether ID administration of regular human insulin or rapid-acting insulin
analogue leads to reduced postprandial glycemic excursions in comparison to SC application
under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia
will also be investigated, as well as pK and pD comparisons between different insulin
formulations administered ID. This is a mono-center, open-label, randomized, 5-period
crossover study in patients with type 1 diabetes
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump
(CSII) in stable control with HbA1c <= 9. 0%.
- Able to attend clinic for 5 different days
Exclusion Criteria:
- BMI > 32 kg/m2
- Evidence of gastroparesis or impaired renal function or lipodystrophy
Locations and Contacts
Christoph Kapitza, MD, Phone: 49 2131/4018-157, Email: Christoph.Kapitza@profil-research.de
Profil Institut fur Stoffwechselforschung GmbH, Neuss D-41460, Germany; Recruiting
Christoph Kapitza, MD, Principal Investigator
Additional Information
Starting date: September 2007
Ending date: January 2008
Last updated: November 2, 2007
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