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Clinical Trial Details

Trial ID: L3776
Source ID: NCT03760640
Associated Drug: Ly900014
Title: A Study of LY900014 in a Medtronic Pump
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03760640/results
Conditions: Type1 Diabetes Mellitus
Interventions: DRUG: LY900014|DRUG: Insulin Lispro
Outcome Measures: Primary: Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour), Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with baseline, period, sequence, strata (Hemoglobin A1c (HbA1c) \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors., Week 2 through Week 4 | Secondary: Mean Sensor Glucose Value (24-Hour), LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors., Week 2 through Week 4|Percentage of Time Spent in Auto Mode, LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors., Week 2 through Week 4|Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour), LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors., Week 2 through Week 4|Rate of Severe Hypoglycemic Events, Severe hypoglycemic is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group \*36525. No severe hypoglycemia was reported for this study., Week 2 through Week 4|Total Daily Insulin Dose, LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors., Week 2 through Week 4
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-02-18
Completion Date: 2019-10-07
Results First Posted: 2020-10-29
Last Update Posted: 2020-10-29
Locations: Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|International Diabetes Center, Saint Louis Park, Minnesota, 55416, United States
URL: https://clinicaltrials.gov/show/NCT03760640