A Phase 2 interventional study of Regular insulin (Humulin) and Insulin lispro (Humalog) in Diabetes Mellitus, Type 1, sponsored by Becton, Dickinson and Company. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2008-08-22.
Sponsored by Becton, Dickinson and Company · Phase 2, Interventional, and Treatment
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
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Becton, Dickinson and Company is the lead sponsor of 60 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Regular insulin SC at -17 mins
Drug: Regular insulin (Humulin)
Regular insulin ID at -17 mins
Drug: Regular insulin (Humulin)
Regular insulin ID at -2 mins
Drug: Regular insulin (Humulin)
Insulin lispro given SC at -2 mins
Drug: Insulin lispro (Humalog)
Insulin lispro given ID at -2 mins
Drug: 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.
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.
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
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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