CLINICAL TRIALS PROFILE FOR FIASP PENFILL
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All Clinical Trials for FIASP PENFILL
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00810589 ↗ | A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial | Completed | Medical University of Graz | Phase 1 | 2008-11-01 | Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insulin glargine. Duration of action of insulin detemir has been reported to be up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is underestimated in glucose clamps lasting only 24 hours. This is so because a duration of action longer than 24 hours in individual clamps will be set to 24 hours in the mean calculation, whereas a shorter duration of action in individual clamps will be set to the true value. It has been shown in clinical pharmacology trials that NPL insulin has an action profile comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date. To get further insight into the pharmacodynamic properties of insulin detemir compared with NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration of action in particular between insulin detemir and NPL insulin in subjects with type 1 diabetes. |
NCT04079413 ↗ | Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients | Completed | Geropharm | Phase 3 | 2019-06-03 | This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®. |
NCT04184466 ↗ | A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects | Completed | Geropharm | N/A | 2018-10-18 | Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin aspart (Insulin Aspart GEROPHARM vers. NovoRapid® Penfill® Novo Nordisk) |
NCT04184492 ↗ | A Study to Compare Pharmacokinetics and Pharmacodynamics of GP-40081 to NovoMix® 30 Penfill® in Healthy Subjects | Completed | Geropharm | N/A | 2019-04-15 | Pharmacokinetics and pharmacodynamics study of 2 formulations of biphasic insulin aspart 30 (GP-40081 GEROPHARM vers. NovoMix® 30 Penfill® Novo Nordisk) |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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Clinical Trial Sponsors for FIASP PENFILL
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