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Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone® Combo | Experimental | 1 single dose 400 U/mL |
|
| Humalog® Mix25 | Active Comparator | 1 single dose 100 U/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biochaperone® Combo | Drug | Subcutaneous injection of an individualized dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Delta AUCBG,0-2h | Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Delta AUCBG,0-6h | Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal | 6 hours |
| BGmax | Maximum blood glucose concentration after a standardised meal (0-6 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hövelmann, MD | Profil Institut Für Stoffwechselfforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Humalog® Mix25 |
| Drug |
Subcutaneous injection of an individualized dose |
|
| 6 hours |
| tBGmax | Time to maximum blood glucose concentration after a standardised meal (0-6 hours) | 6 hours |
| AUCLisp,0-6h, | Area under the plasma insulin lispro concentration-time curve from 0-6 hours | 6 hours |
| AUCGlarg,0-6h | Area under the plasma insulin glargine concentration-time curve from 0-6 hours | 6 hours |
| Cmax,Lisp | Maximum observed plasma insulin lispro concentration | 6 hours |
| Cmax,Glarg | Maximum observed plasma insulin glargine concentration | 6 hours |
| Adverse events | Number of adverse events | Up to 7 weeks |
| Local tolerability | Number and intensity of injection site reactions | Up to 7 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |