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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).
To compare the total pharmacodynamic response of URAL and insulin lispro.
To compare the total pharmacokinetic exposure between URAL and insulin lispro.
To assess the safety and tolerability of URAL and insulin lispro.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| URAL vs. Insulin lispro | Experimental | Each subject will randomly be allocated to a treatment sequence consisting of 2 dosing visits during which the subject in a euglycaemic clamp setting will receive either a single dose of insulin lispro or URAL at predefined fixed dose levels in a randomized order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| URAL | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of URAL | Area under the serum insulin lispro concentration-time curve from 0-30 minutes after administration | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of appearance of serum insulin lispro | Measurement of time to reach insulin lispro concentration >30 pmol/L in the serum | 1 day |
| Number of subjects with adverse events | Assessment of safety and tolerability of URAL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alin Stirban, MD | Profil Institut fur Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut fur Stoffwechselforschung GmbH | Neuss | Germany |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 1 day |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |