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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.
First Received: October 12, 2007   Last Updated: August 21, 2008   History of Changes
Sponsor: Becton, Dickinson and Company
Information provided by: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT00553488
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Regular insulin (Humulin)
Drug: Insulin lispro (Humalog)
 Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1
Drug Information available for: Insulin Insulin lispro
U.S. FDA Resources

Further study details as provided by Becton, Dickinson and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Regular insulin SC at -17 mins
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.
2: Active Comparator
Regular insulin ID at -17 mins
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.
3: Active Comparator
Regular insulin ID at -2 mins
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.
4: Active Comparator
Insulin lispro given SC at -2 mins
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.
5: Experimental
Insulin lispro given ID at -2 mins
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.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553488

Locations
Germany
Profil Institut fur Stoffwechselforschung GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
Principal Investigator: Christoph Kapitza, MD Profil Institut fur Stoffwechselforschung GmbH
  More Information

No publications provided

Responsible Party: BD ( Laurence Hirsch, Vice-President, Global Medical Affairs, Diabetes Care )
Study ID Numbers: BDT-ADD-07-002, EudraCT number 2007-003924-39
Study First Received: October 12, 2007
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00553488     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Becton, Dickinson and Company:
diabetes
insulin
subcutaneous
intra-dermal
blood glucose

Additional relevant MeSH terms:
Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs
 Diabetes Mellitus
Insulin LISPRO
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 22, 2009



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