Clinical trial NCT00553488: Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes
insulin
subcutaneous
intra-dermal
blood glucose
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
timeFrame: 90 mins
Secondary outcomes:
measure: Maximal BG (BGmax)
timeFrame: Approximately 4 hours per injection
measure: Total BG-AUC0-4 h
timeFrame: Approximately 4 hrs per injection
measure: Minimal BG (BGmin, time to BGmin (tBGmin)
timeFrame: Approximately 4 hrs per injection
measure: Insulin pharmacokinetics
timeFrame: Approximately 4 hrs per injection
measure: Number and seriousness of adverse events
timeFrame: Approximately 4 hrs per injections
measure: Vital signs, examination of insulin application
timeFrame: Approximately 4 hrs per injection
measure: Time to BGmax (tBGmax)
timeFrame: Approximately 4 hours per injection
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut fur Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut fur Stoffwechselforschung GmbH
name: Christoph Kapitza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pettis RJ, Hirsch L, Kapitza C, Nosek L, Hovelmann U, Kurth HJ, Sutter DE, Harvey NG, Heinemann L. Microneedle-based intradermal versus subcutaneous administration of regular human insulin or insulin lispro: pharmacokinetics and postprandial glycemic excursions in patients with type 1 diabetes. Diabetes Technol Ther. 2011 Apr;13(4):443-50. doi: 10.1089/dia.2010.0183. Epub 2011 Feb 28.