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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: December 2007

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

Intervention(s) in this Clinical Trial

• Drug: Regular insulin (Humulin)
  • Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
• Drug: Insulin lispro (Humalog)
  • Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Regular insulin SC at -17 mins
• Active Comparator: 2
  • Regular insulin ID at -17 mins
• Active Comparator: 3
  • Regular insulin ID at -2 mins
• Active Comparator: 4
  • Insulin lispro given SC at -2 mins
• Experimental: 5
  • Insulin lispro given ID at -2 mins

Primary Measures

• Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
  • Time Frame: 90 mins
    Safety Issue?: No

Secondary Measures

• Maximal BG (BGmax)
  • Time Frame: Approximately 4 hours per injection
    Safety Issue?: No
• Total BG-AUC0-4 h
  • Time Frame: Approximately 4 hrs per injection
    Safety Issue?: No
• Minimal BG (BGmin, time to BGmin (tBGmin)
  • Time Frame: Approximately 4 hrs per injection
    Safety Issue?: No
• Insulin pharmacokinetics
  • Time Frame: Approximately 4 hrs per injection
    Safety Issue?: No
• Number and seriousness of adverse events
  • Time Frame: Approximately 4 hrs per injections
    Safety Issue?: Yes
• Vital signs, examination of insulin application
  • Time Frame: Approximately 4 hrs per injection
    Safety Issue?: No
• Time to BGmax (tBGmax)
  • Time Frame: Approximately 4 hours per injection
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Becton, Dickinson and Company

Overall Clinical Trial Officials and Contacts

Christoph Kapitza, MD Principal Investigator Profil Institut fur Stoffwechselforschung GmbH  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00553488

Study ID Number: BDT-ADD-07-002

ClinicalTrials.gov Identifier: NCT00553488

Health Authority: Germany: Federal Institute for Drugs and Medical Devices