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Completed

NCT Number: NCT00553488

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Profil Institut fur Stoffwechselforschung GmbH

Neuss, D-41460, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular insulin (Humulin)

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.

Insulin Lispro (Humalog)

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.

Primary outcomes

  1. Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.

    Time frame: 90 mins

Secondary outcomes

  1. Maximal BG (BGmax)

    Time frame: Approximately 4 hours per injection

  2. Total BG-AUC0-4 h

    Time frame: Approximately 4 hrs per injection

  3. Minimal BG (BGmin, time to BGmin (tBGmin)

    Time frame: Approximately 4 hrs per injection

  4. Insulin pharmacokinetics

    Time frame: Approximately 4 hrs per injection

  5. Number and seriousness of adverse events

    Time frame: Approximately 4 hrs per injections

  6. Vital signs, examination of insulin application

    Time frame: Approximately 4 hrs per injection

  7. Time to BGmax (tBGmax)

    Time frame: Approximately 4 hours per injection

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Nov 5, 2007
Registry last updated
Aug 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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