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Clinical Trial Details

Trial ID: L5787
Source ID: NCT04867785
Associated Drug: Ly3437943
Title: A Study of LY3437943 in Participants With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04867785/results
Conditions: Type 2 Diabetes
Interventions: DRUG: LY3437943|DRUG: Dulaglutide|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c), Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time., Baseline, 24 Weeks | Secondary: Change From Baseline in HbA1c, Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time., Baseline, 24 Weeks|Change From Baseline in HbA1c, Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline Body Mass Index (BMI) Group (\<30 kilograms/square meter (kg/m2), \>=30 kg/m2)\*Time + Baseline\*Time., Baseline, 36 Weeks|Percentage of Participants Reaching HbA1c <7.0%, Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate., Week 24|Percentage of Participant Reaching HbA1c <7.0%, Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate., Week 36|Change From Baseline in Fasting Blood Glucose (FBG), Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time., Baseline, 24 Weeks|Change From Baseline in Fasting Blood Glucose (FBG), Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time., Baseline, 36 Weeks|Change From Baseline in Body Weight, Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time., Baseline, 24 Weeks|Change From Baseline in Body Weight, Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time., Baseline, 36 Weeks|Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943, The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling., Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 281
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-05-13
Completion Date: 2022-10-27
Results First Posted: 2023-07-03
Last Update Posted: 2023-07-03
Locations: Syed Research Consultants Llc, Sheffield, Alabama, 35660, United States|San Fernando Valley Health Institute, Canoga Park, California, 91304, United States|Valley Endocrine, Fresno, Fresno, California, 93720, United States|National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|National Research Institute - Panorama City, Panorama City, California, 91402, United States|Anderson Clinical Research, Redlands, California, 92374, United States|Artemis Institute for Clinical Research, Riverside, California, 92503, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|National Research Institute (NRI) - Santa Ana, Santa Ana, California, 92704, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|South Florida Clinical Research Institute, Margate, Florida, 33063, United States|ForCare Clinical Research, Tampa, Florida, 33613, United States|Encore Medical Research - Weston, Weston, Florida, 33331, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Humphreys Diabetes Center, Boise, Idaho, 83702, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Elite Clinical Trials, Rexburg, Idaho, 83440, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States|Centennial Medical Group, Elkridge, Maryland, 21075, United States|MediSync Clinical Research, Petal, Mississippi, 39465, United States|Clinvest Research LLC, Springfield, Missouri, 65810, United States|Logan Health Research, Kalispell, Montana, 59901, United States|Lillestol Research, Fargo, North Dakota, 58104, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Preferred Primary Care Physicians, Pittsburgh, Pennsylvania, 15236, United States|Frontier Clinical Research, LLC, Smithfield, Pennsylvania, 15478, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|The Research Center of The Upstate, Greenville, South Carolina, 29607, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas, 76132, United States|Endocrine Ips, Pllc, Houston, Texas, 77079, United States|Laila A Hassan, MD, PA, Houston, Texas, 77089, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|North Hills Family Medicine/North Hills Medical Research, North Richland Hills, Texas, 76180, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Universal Research Group, Tacoma, Washington, 98405, United States|The Vancouver Clinic, Vancouver, Washington, 98664, United States|Advanced Clinical Research, LLC, Bayamon, 00961, Puerto Rico|Manati Center for Clinical Research, Manati, 674, Puerto Rico|Latin Clinical Trial Center, San Juan, 909, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT04867785