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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553488
• Other study ID #: BDT-ADD-07-002
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2007
• Last updated: August 21, 2008
• Start date: September 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2008
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Profil Institut fur Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.		90 mins	No
Secondary	Maximal BG (BGmax)		Approximately 4 hours per injection	No
Secondary	Total BG-AUC0-4 h		Approximately 4 hrs per injection	No
Secondary	Minimal BG (BGmin, time to BGmin (tBGmin)		Approximately 4 hrs per injection	No
Secondary	Insulin pharmacokinetics		Approximately 4 hrs per injection	No
Secondary	Number and seriousness of adverse events		Approximately 4 hrs per injections	Yes
Secondary	Vital signs, examination of insulin application		Approximately 4 hrs per injection	No
Secondary	Time to BGmax (tBGmax)		Approximately 4 hours per injection	No