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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human 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
Active Comparator: 1 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. Other Name: Regular insulin (Humulin)
Active Comparator: 2 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. Other Name: Regular insulin (Humulin)
Active Comparator: 3 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. Other Name: Regular insulin (Humulin)
Active Comparator: 4 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. Other Name: Insulin lispro (Humalog)
Experimental: 5 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. Other Name: Insulin lispro (Humalog)

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 by Becton, Dickinson and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Feb 28.

Responsible Party:	Laurence Hirsch, Vice-President, Global Medical Affairs, Diabetes Care, BD
ClinicalTrials.gov Identifier:	NCT00553488 History of Changes
Other Study ID Numbers:	BDT-ADD-07-002, EudraCT number 2007-003924-39
Study First Received:	October 12, 2007
Last Updated:	August 21, 2008
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:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013