Clinical Trial Details
| Trial ID: | L6471 |
| Source ID: | NCT04101383 |
| Associated Drug: | Ringlar® |
| Title: | A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Clamp Study |
| Interventions: | DRUG: RinGlar®|DRUG: Lantus® |
| Outcome Measures: | Primary: AUC GIR(0-t), Pharmacodynamic of insulin glargine by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t)), 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose|AUC(0-t), Pharmacokinetics of insulin glargine by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t)), -60, -30 and 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose | |
| Sponsor/Collaborators: | Sponsor: Geropharm |
| Gender: | MALE |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 42 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2017-10-16 |
| Completion Date: | 2018-02-16 |
| Results First Posted: | |
| Last Update Posted: | 2019-09-24 |
| Locations: | Endocrinology Research Centre, Moscow, 117036, Russian Federation|Almazov National Medical Research Centre, Saint Petersburg, 197341, Russian Federation |
| URL: | https://clinicaltrials.gov/show/NCT04101383 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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