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Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating

This study has been completed.
Sponsor:
Information provided by:
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT00553488
First received: October 12, 2007
Last updated: August 21, 2008
Last verified: August 2008

October 12, 2007
August 21, 2008
September 2007
December 2007   (final data collection date for primary outcome measure)
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. [ Time Frame: 90 mins ] [ Designated as safety issue: No ]
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. [ Time Frame: 90 mins ]
Complete list of historical versions of study NCT00553488 on ClinicalTrials.gov Archive Site
  • Maximal BG (BGmax) [ Time Frame: Approximately 4 hours per injection ] [ Designated as safety issue: No ]
  • Total BG-AUC0-4 h [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
  • Minimal BG (BGmin, time to BGmin (tBGmin) [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
  • Insulin pharmacokinetics [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
  • Number and seriousness of adverse events [ Time Frame: Approximately 4 hrs per injections ] [ Designated as safety issue: Yes ]
  • Vital signs, examination of insulin application [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
  • Time to BGmax (tBGmax) [ Time Frame: Approximately 4 hours per injection ] [ Designated as safety issue: No ]
• 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 [ Time Frame: Approximately 4 hours per injection ]
Not Provided
Not Provided
 
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • 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.
    Other Name: Regular insulin (Humulin)
  • 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.
    Other Name: Insulin lispro (Humalog)
  • Active Comparator: 1
    Regular insulin SC at -17 mins
    Intervention: Drug: Regular insulin (Humulin)
  • Active Comparator: 2
    Regular insulin ID at -17 mins
    Intervention: Drug: Regular insulin (Humulin)
  • Active Comparator: 3
    Regular insulin ID at -2 mins
    Intervention: Drug: Regular insulin (Humulin)
  • Active Comparator: 4
    Insulin lispro given SC at -2 mins
    Intervention: Drug: Insulin lispro (Humalog)
  • Experimental: 5
    Insulin lispro given ID at -2 mins
    Intervention: Drug: Insulin lispro (Humalog)
Pettis RJ, Hirsch L, Kapitza C, Nosek L, Hövelmann 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2008
December 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00553488
BDT-ADD-07-002, EudraCT number 2007-003924-39
No
Laurence Hirsch, Vice-President, Global Medical Affairs, Diabetes Care, BD
Becton, Dickinson and Company
Not Provided
Principal Investigator: Christoph Kapitza, MD Profil Institut fur Stoffwechselforschung GmbH
Becton, Dickinson and Company
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP