Clinical Trial Details
| Trial ID: | L7228 |
| Source ID: | NCT03449433 |
| Associated Drug: | Ly900014 |
| Title: | A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03449433/results |
| Conditions: | Diabetes Mellitus, Type 1 |
| Interventions: | DRUG: LY900014|DRUG: Insulin Lispro|DRUG: Insulin Aspart|DRUG: Insulin Aspart |
| Outcome Measures: | Primary: Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm, PK: Insulin Lispro or Insulin Aspart AUC(0-7h), 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose | Secondary: Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT), PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT), Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose |
| Sponsor/Collaborators: | Sponsor: Eli Lilly and Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 80 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2018-03-15 |
| Completion Date: | 2018-08-14 |
| Results First Posted: | 2020-04-30 |
| Last Update Posted: | 2020-04-30 |
| Locations: | Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, 41460, Germany |
| URL: | https://clinicaltrials.gov/show/NCT03449433 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|