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This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 - GZR-33, period 2 insulin degludec | Experimental | Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days |
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| Period 1 - insulin degludec, period 2 - GZR-33 | Experimental | Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR-33 | Drug | GZR33 is a long-acting basal insulin analogue |
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| Measure | Description | Time Frame |
|---|---|---|
| the relative potency of GZR33 to insulin degludec | Primary endpoint will be the relative potency of GZR33 to insulin degludec, according to the following equation: Relative Potency = GIR24h,ss,GZR33 /GIR24h,ss,degludec) × (Dosedegludec/DoseGZR33). | a two week run-in phase |
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Inclusion Criteria: type 1 diabetes for at least 12 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre Feldmann | Contact | +49 (0) 2131 4018 409 | 149-1226-GZR-33@profil.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut | Recruiting | Neuss | 41460 | Germany | ||
| Profil |
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| Recruiting |
| Neuss |
| Germany |
|