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Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin lispro preparations
To evaluate the single dose safety and local tolerability of the three insulin lispro preparations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gan & Lee Insulin Lispro Injection | Experimental | Insulin lispro, 3 mL cartridge in prefilled pen, 100 units/mL (U-100) |
|
| EU - approved Humalog ® | Active Comparator | Insulin lispro (product approved and marketed in the EU), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100) |
|
| US - licensed Humalog ® | Active Comparator | Insulin lispro (product approved and marketed in the US), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gan & Lee Insulin Lispro Injection | Drug | All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCins.0-12h | PK Endpoint: The area under the insulin concentration curve from 0 to 12 hours. | 0 to 12 hours |
| Cins.max | PK Endpoint: The maximum observed insulin concentration. | 0 to 12 hours |
| AUCGIR.0-12h | PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours. | 0 to 12 hours |
| GIRmax | PD endpoint: The maximum glucose infusion rate. | 0 to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCins.0-2h | PK endpoint: The area under the insulin concentration curve from 0 to 2 hours | 0 to 2 hours |
| AUCins.0-4h | PK endpoint: The area under the insulin concentration curve from 0 to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
Explanatory note on Exclusion Criterion 24: With the exception of paracetamol or NSAIDs for occasional use to treat acute pain, as judged by the Investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Jia Lu, PhD | Gan & Lee Pharmaceuticals, USA | Study Director |
| Leona Plum - Mörschel, Dr. med | Profil Mainz GmbH & Co KG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Mainz GmbH & Co. KG | Mainz | 55116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37735841 | Derived | Chen W, Lu J, Plum-Morschel L, Andersen G, Zijlstra E, He A, Xie T, Li L, Hao C, Gan Z, Heise T. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin(R)), lispro (prandilin(R)) and glargine (basalin(R)) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023 Dec;25(12):3817-3825. doi: 10.1111/dom.15281. Epub 2023 Sep 21. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C027235 | gallium nitrate |
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This is a phase 1 trial. The trial is a single center, randomized, doubleblind, single dose, there treatment, three period crossover, 12 - hour euglycaemic glucose clamp trial in healthy male subjects.
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| 0 to 4 hours |
| AUCins.0-6h | PK endpoint: The area under the insulin concentration curve from 0 to 6 hours | 0 to 6 hours |
| AUCins.6-12h | PK endpoint: The area under the insulin concentration curve from 0 to 12 hours | 6 to 12 hours |
| AUCins.0-∞ | PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity | 0 to 12 hours |
| tins.max | PK endpoint: The time to maximum observed insulin concentration t½, terminal serum elimination half-life calculated as t½=ln2/λz | 0 to 12 hours |
| t50%-ins(early) | PK endpoint: The time to half-maximum insulin concentration before Cins.max | 0 to 12 hours |
| t50%-ins(late) | PK endpoint: The time to half-maximum insulin concentration after Cins.max | 0 to 12 hours |
| t½ | PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz | 0 to 12 hours |
| λz | PK endpoint: The terminal elimination rate constant of insulin | 0 to 12 hours |
| AUCGIR.0-2h | PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours | 0 to 2 hours |
| AUCGIR.0-4h | PD endpoint: The area under the glucose infusion rate curve from 0 to 4 hours | 0 to 4 hours |
| AUCGIR.0-6h | PD endpoint: The area under the glucose infusion rate curve from 0 to 6 hours | 0 to 6 hours |
| AUCGIR.6-12h | PD endpoint: The area under the glucose infusion rate curve from 6 to 12 hours | 6 to 12 hours |
| tGIR.max | PD endpoint: The time to maximum glucose infusion rate | 0 to 12 hours |
| tGIR.50%-early | PD endpoint: The time to half-maximum glucose infusion rate before GIRmax | 0 to 12 hours |
| tGIR.50%-late | PD endpoint: The time to half-maximum glucose infusion rate after GIRmax | 0 to 12 hours |
| PD endpoint | time to onset of action | 0 to 12 hours |
| Safety and Local Tolerability | Number of participants experiencing treatment-emergent adverse events | 0 to 12 hours |
| D006946 | Hyperinsulinism |