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

Becton, Dickinson and Company (BD)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Regular insulin (Humulin); Drug: Insulin lispro (Humalog)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553488

EudraCT number 2007-003924-39

BDT-ADD-07-002

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

1

Active Comparator group

Description:

Regular insulin SC at -17 mins

Treatment:

Drug: Regular insulin (Humulin)

2

Active Comparator group

Description:

Regular insulin ID at -17 mins

Treatment:

Drug: Regular insulin (Humulin)

3

Active Comparator group

Description:

Regular insulin ID at -2 mins

Treatment:

Drug: Regular insulin (Humulin)

4

Active Comparator group

Description:

Insulin lispro given SC at -2 mins

Treatment:

Drug: Insulin lispro (Humalog)

5

Experimental group

Description:

Insulin lispro given ID at -2 mins

Treatment:

Drug: Insulin lispro (Humalog)