Diabetes Mellitus, Type 1
Conditions
Keywords
diabetes, insulin, subcutaneous, intra-dermal, blood glucose
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
Interventions
DRUGRegular 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 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.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. | 90 mins |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Maximal BG (BGmax) | Approximately 4 hours per injection |
| Vital signs, examination of insulin application | Approximately 4 hrs per injection |
| Time to BGmax (tBGmax) | Approximately 4 hours per injection |
| Number and seriousness of adverse events | Approximately 4 hrs per injections |
Countries
Germany
Outcome results
None listed