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

August 21, 2008 updated by: Becton, Dickinson and Company

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, D-41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
Time Frame: 90 mins
90 mins

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal BG (BGmax)
Time Frame: Approximately 4 hours per injection
Approximately 4 hours per injection
Total BG-AUC0-4 h
Time Frame: Approximately 4 hrs per injection
Approximately 4 hrs per injection
Minimal BG (BGmin, time to BGmin (tBGmin)
Time Frame: Approximately 4 hrs per injection
Approximately 4 hrs per injection
Insulin pharmacokinetics
Time Frame: Approximately 4 hrs per injection
Approximately 4 hrs per injection
Number and seriousness of adverse events
Time Frame: Approximately 4 hrs per injections
Approximately 4 hrs per injections
Vital signs, examination of insulin application
Time Frame: Approximately 4 hrs per injection
Approximately 4 hrs per injection
Time to BGmax (tBGmax)
Time Frame: Approximately 4 hours per injection
Approximately 4 hours per injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Investigators

  • Principal Investigator: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

October 12, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 22, 2008

Last Update Submitted That Met QC Criteria

August 21, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDT-ADD-07-002
  • EudraCT number 2007-003924-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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