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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study is constituted of 2 parts:
Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:
Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.
Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone insulin lispro | Experimental |
| |
| Humalog® | Active Comparator | Insulin lispro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioChaperone insulin lispro | Drug | BioChaperone insulin lispro bolus infusion followed by test meal intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: ΔAUCBG 0-2h | Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal. | 2 Hours |
| Pharmacokinetics: AUClis 0-30min | Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| AUClis_0-6h | Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose | up to 6 Hours |
| Cmax | Maximum insulin Concentration following a bolus dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Heise, MD | Profil GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil GmbH | Neuss | 41460 | Germany |
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| Humalog® | Drug | Humalog® bolus infusion followed by test meal intake |
|
| up to 6 Hours |
| tCmax | Time to Maximum insulin Concentration following a bolus dose | up to 6 Hours |
| BGmax | Maximum Blood Glucose after start of an individualised standardised meal intake | up to 6 Hours |
| tBGmax | Time to Maximum Blood Glucose concentration | up to 6 Hours |
| Compatibility | Number of suspected episodes of infusion set occlusion or leakage | up to 14 days |
| Adverse Events | Number of Adverse Events | up to 12 weeks |
| Local tolerability | Number of injection site reactions | up to 12 weeks |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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