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Clinical Trial Details

Trial ID: L4322
Source ID: NCT05048719
Associated Drug: Ly3502970
Title: A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05048719/results
Conditions: Type 2 Diabetes
Interventions: DRUG: LY3502970|DRUG: Dulaglutide|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in HbA1c in LY3502970 as Compared to Placebo, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26 | Secondary: Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26|Percentage of Participants With HbA1c ≤ 6.5%, Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model., Week 26|Percentage of Participants With HbA1c <7.0%, Percentage of Participants with HbA1c \<7.0%. Odds ratio was calculated using logistic regression model., Week 26|Change From Baseline in Fasting Serum Glucose, Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, 8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26|Change From Baseline in Body Weight, LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26|Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970, PK: Steady State AUC of LY3502970, Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 383
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-09-15
Completion Date: 2022-09-30
Results First Posted: 2023-10-17
Last Update Posted: 2023-10-17
Locations: Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Velocity Clinical Research, Huntington Park, Huntington Park, California, 90255, United States|Velocity Clinical Research, Westlake, Los Angeles, California, 90057, United States|Rancho Cucamonga Clinical Research, Rancho Cucamonga, California, 91730, United States|Touro University California, Vallejo, California, 94592, United States|New West Physicians Clinical Research, Golden, Colorado, 80401, United States|Optumcare Colorado Springs - Monument, Monument, Colorado, 80132, United States|Cotton O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Premier Research, Trenton, New Jersey, 08611, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Capital Area Research, LLC, Camp Hill, Pennsylvania, 17011, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|Tristar Clinical Investigations, Philadelphia, Pennsylvania, 19114, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Biopharma Informatic, LLC, Houston, Texas, 77084, United States|Bandera Family Health Care, San Antonio, Texas, 78249, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Capital Clinical Research Center, Olympia, Washington, 98502, United States|Eastside Research Associates, Redmond, Washington, 98052, United States|Bugát Pál Kórház, Gyongyos, Heves, 3200, Hungary|Kanizsai Dorottya Korhaz, Nagykanizsa, Zala, 8800, Hungary|Zala Megyei Szent Rafael Kórház, Zalaegerszeg, Zala, 8900, Hungary|Szent Margit Rendelőintézet Nonprofit Kft, Budapest, 1032, Hungary|Clinexpert Kft., Budapest, 1033, Hungary|ClinDiab Kft., Budapest, 1089, Hungary|TRANTOR'99 Bt. Anyagcsere Centrum, Budapest, 1213, Hungary|Strazsahegy Medicina Bt., Budapest, H1171, Hungary|Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej, Wrocław, Dolnośląskie, 50-403, Poland|Gabinety TERPA, Lublin, Lubelskie, 20-333, Poland|NZOZ Medica, Lublin, Lubelskie, 20-538, Poland|Centralny Szpital Kliniczny MSWiA w Warszawie, Warszawa, Mazowieckie, 02-507, Poland|Centrum Zdrowia Tuchów, Wierzchosławice, Małopolskie, 33-122, Poland|Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz, Łódzkie, Poland|NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ruda Slaska, Śląskie, 41-709, Poland|Dorado Medical Complex, Dorado, 00646, Puerto Rico|Clinical Research Management Group Inc. - Hospital San Cristobal, Ponce, 00780, Puerto Rico|BRCR Global Puerto Rico-Unda, San Juan, 00907, Puerto Rico|Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA, Bratislava, Bratislavský Kraj, 831 06, Slovakia|Diabetol, Prešov, Prešovský Kraj, 080 01, Slovakia|MEDI-DIA s.r.o., Sabinov, Prešovský Kraj, 083 01, Slovakia|DIA-MED CENTRUM s.r.o., Puchov, Trenčiansky Kraj, 020 01, Slovakia|Funkystuff, Nove Zamky, 940 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT05048719

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress