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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone insulin lispro | Experimental |
| |
| Humalog® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioChaperone insulin lispro | Drug | Injection immediately before the start of the individualised standard meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: ΔAUCBG 0-2h | Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro) | 2 hours |
| Pharmacokinetics: AUClis 0-30min | Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| AUClisp_0-6h | Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose | up to 6 hours |
| Cmax_lisp | Maximum serum insulin lispro Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grit Andersen, MD | Profil GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Mainz GmbH & Co.KG | Mainz | 44116 | Germany | |||
| Profil GmbH |
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| Humalog® | Drug | Injection immediately before the start of the individualised standard meal |
|
| up to 6 hours |
| tmax_lisp | Time to maximum observed serum insulin lispro concentration | up to 6 hours |
| CmaxBG | Maximum Blood Glucose after an individualised standard meal | up to 6 hours |
| AUCBG_0-6h | Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours | up to 6 hours |
| Adverse Events | Number of Adverse Events | up to 8 weeks |
| Local tolerability | Record of injection site reaction | up to 8 weeks |
| Neuss |
| 41460 |
| Germany |
| 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 |
|---|---|
| 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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