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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Regular insulin (Humulin); Drug: Insulin lispro (Humalog)

• Registration Number: NCT00553488
• Lead Sponsor: Becton, Dickinson and Company

Brief 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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-12
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-21
• Last Update Posted: 2008-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Read More

Exclusion Criteria

• BMI > 32 kg/m2
• Evidence of gastroparesis or impaired renal function or lipodystrophy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Regular insulin (Humulin)	Regular insulin SC at -17 mins
2	Regular insulin (Humulin)	Regular insulin ID at -17 mins
3	Regular insulin (Humulin)	Regular insulin ID at -2 mins
4	Insulin lispro (Humalog)	Insulin lispro given SC at -2 mins
5	Insulin lispro (Humalog)	Insulin lispro given ID at -2 mins

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Profil Institut fur Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany