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Clinical Trial Details

Trial ID: L6042
Source ID: NCT02588950
Associated Drug: U-500r
Title: A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02588950/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: U-500R
Outcome Measures: Primary: Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R, Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R., Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose|Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R, Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC\[0-24\]) of U-500R., Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose|Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R, Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R., Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose|Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R, Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R., Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose | Secondary: Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R, Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC\[0-tlast\]) of U-500R., Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose|Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R, Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R., Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose|Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R, Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R., Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose|Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R, Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R., Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose|Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R, Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R., Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 11
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2016-01-12
Completion Date: 2017-05-25
Results First Posted: 2023-10-18
Last Update Posted: 2023-10-23
Locations: Profil Institute for Clinical Research, Chula Vista, California, 91911, United States
URL: https://clinicaltrials.gov/show/NCT02588950

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress