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This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biochaperone Combo | Experimental | single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy |
|
| Humalog Mix25 | Active Comparator | single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy |
|
| Humalog and Lantus | Active Comparator | simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biochaperone Combo | Drug | Injection of BioChaperone Combo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg) | Area under the glucose infusion rate curve from 12 hours to 30 hours | from 12h to 30 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCGIR 0-last (mg/kg) | Area under the glucose infusion rate curve from 0 hours until the end of clamp | Up to 30 hours |
| GIRmax (mg/kg/min) | Maximum glucose infusion rate |
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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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| Humalog Mix25 |
| Drug |
Injection of Humalog Mix25 |
|
| Humalog | Drug | Injection of Humalog |
|
| Lantus | Drug | Injection of Lantus |
|
| Placebo | Drug | Injection of saline 0.9% solution |
|
| Up to 30 hours |
| tGIRmax | Time to maximum glucose infusion rate | Up to 30 hours |
| AUCLis 0-30h | Area under the insulin lispro plasma concentration time curve | Up to 30 hours |
| AUCGla 0-30h | Area under the insulin glargine plasma concentration time curve | Up to 30 hours |
| tmax Gla | Time to maximum insulin glargine plasma concentration | Up to 30 hours |
| tmax Lis | Time to maximum insulin lispro plasma concentration | Up to 30 hours |
| Adverse events | Number of adverse events | Up to 9 weeks |
| Hypoglycaemic episodes | Number of Hypoglycaemic episodes | Up to 9 weeks |
| Local tolerability | Number and intensity of injection site reactions | Up to 9 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C482266 | insulin lispro, isophane insulin lispro drug combination (25:75) |
| D061268 | Insulin Lispro |
| D000069036 | Insulin Glargine |
| 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 |
| D049528 | Insulin, Long-Acting |
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