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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Profil Institut fur Stoffwechselforschung GmbH
Neuss, Germany
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
Time frame: 90 mins
Maximal BG (BGmax)
Time frame: Approximately 4 hours per injection
Total BG-AUC0-4 h
Time frame: Approximately 4 hrs per injection
Minimal BG (BGmin, time to BGmin (tBGmin)
Time frame: Approximately 4 hrs per injection
Insulin pharmacokinetics
Time frame: Approximately 4 hrs per injection
Number and seriousness of adverse events
Time frame: Approximately 4 hrs per injections
Vital signs, examination of insulin application
Time frame: Approximately 4 hrs per injection
Time to BGmax (tBGmax)
Time frame: Approximately 4 hours per injection
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