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.
Primary Outcome Measures:
- Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. [ Time Frame: 90 mins ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximal BG (BGmax) [ Time Frame: Approximately 4 hours per injection ] [ Designated as safety issue: No ]
- Total BG-AUC0-4 h [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
- Minimal BG (BGmin, time to BGmin (tBGmin) [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
- Insulin pharmacokinetics [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
- Number and seriousness of adverse events [ Time Frame: Approximately 4 hrs per injections ] [ Designated as safety issue: Yes ]
- Vital signs, examination of insulin application [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
- Time to BGmax (tBGmax) [ Time Frame: Approximately 4 hours per injection ] [ Designated as safety issue: No ]
| Enrollment: |
30 |
| Study Start Date: |
September 2007 |
| Study Completion Date: |
January 2008 |
| Primary Completion Date: |
December 2007 (Final data collection date for primary outcome measure) |
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1: Active Comparator
Regular insulin SC at -17 mins
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Drug: Regular 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.
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2: Active Comparator
Regular insulin ID at -17 mins
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Drug: Regular 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.
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3: Active Comparator
Regular insulin ID at -2 mins
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Drug: Regular 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.
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4: Active Comparator
Insulin lispro given SC at -2 mins
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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.
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5: Experimental
Insulin lispro given ID at -2 mins
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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.
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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
Purpose
