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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2007-003924-39 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Regular insulin SC at -17 mins |
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| 2 | Active Comparator | Regular insulin ID at -17 mins |
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| 3 | Active Comparator | Regular insulin ID at -2 mins |
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| 4 | Active Comparator | Insulin lispro given SC at -2 mins |
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| 5 | Experimental | Insulin lispro given ID at -2 mins |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular insulin (Humulin) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. | 90 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal BG (BGmax) | Approximately 4 hours per injection | |
| Total BG-AUC0-4 h | Approximately 4 hrs per injection | |
| Minimal BG (BGmin, time to BGmin (tBGmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Kapitza, MD | Profil Institut fur Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut fur Stoffwechselforschung GmbH | Neuss | D-41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21355716 | Derived | Pettis RJ, Hirsch L, Kapitza C, Nosek L, Hovelmann U, Kurth HJ, Sutter DE, Harvey NG, Heinemann L. Microneedle-based intradermal versus subcutaneous administration of regular human insulin or insulin lispro: pharmacokinetics and postprandial glycemic excursions in patients with type 1 diabetes. Diabetes Technol Ther. 2011 Apr;13(4):443-50. doi: 10.1089/dia.2010.0183. Epub 2011 Feb 28. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061386 | Insulin, Regular, Human |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin lispro (Humalog) | Drug | 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. |
|
| Approximately 4 hrs per injection |
| Insulin pharmacokinetics | Approximately 4 hrs per injection |
| Number and seriousness of adverse events | Approximately 4 hrs per injections |
| Vital signs, examination of insulin application | Approximately 4 hrs per injection |
| Time to BGmax (tBGmax) | Approximately 4 hours per injection |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |