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

NCT ID: NCT00553488

Last Updated: 2008-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Diabetes Mellitus, Type 1

Keywords

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diabetes insulin subcutaneous intra-dermal blood glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Regular insulin SC at -17 mins

Group Type ACTIVE_COMPARATOR

Regular insulin (Humulin)

Intervention Type DRUG

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

Regular insulin ID at -17 mins

Group Type ACTIVE_COMPARATOR

Regular insulin (Humulin)

Intervention Type DRUG

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

Regular insulin ID at -2 mins

Group Type ACTIVE_COMPARATOR

Regular insulin (Humulin)

Intervention Type DRUG

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

Insulin lispro given SC at -2 mins

Group Type ACTIVE_COMPARATOR

Insulin lispro (Humalog)

Intervention Type DRUG

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

Insulin lispro given ID at -2 mins

Group Type EXPERIMENTAL

Insulin lispro (Humalog)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Becton, Dickinson and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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BD

Principal Investigators

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Christoph Kapitza, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut fur Stoffwechselforschung GmbH

Locations

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Profil Institut fur Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

References

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Pettis RJ, Hirsch L, Kapitza C, Nosek L, Hovelmann 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.

Reference Type DERIVED
PMID: 21355716 (View on PubMed)

Other Identifiers

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EudraCT number 2007-003924-39

Identifier Type: -

Identifier Source: secondary_id

BDT-ADD-07-002

Identifier Type: -

Identifier Source: org_study_id