| Outcome Measures: |
Primary: Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response, HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean., Baseline, Week 26 | Secondary: Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response, HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean., Baseline, Week 12|Change From Baseline to Week 26 in HbA1c, HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time., Baseline, Week 26|Change From Baseline to Week 12 in HbA1c, HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time., Baseline, Week 12|Change From Baseline in Body Weight, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time., Baseline, Week 26|Percentage of Participants With 5% or Greater Body Weight Loss From Baseline, Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors., Week 26|Percentage of Participants With 10% or Greater Body Weight Loss From Baseline, Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors., Week 26|Percentage of Participants Reaching the HbA1c Target of ≤6.5%, Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors., Week 26|Percentage of Participants Reaching the HbA1c Target of <7.0%, Percentage of participants with HbA1c \<7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors., Week 26|Change From Baseline in Fasting Blood Glucose, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time., Baseline, Week 26|Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment\*time., Baseline, Week 26|Change From Baseline in Total Cholesterol, LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time., Baseline, Week 26|Change From Baseline in Triglycerides, LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time., Baseline, Week 26|Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C), LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time., Baseline, Week 26|Change From Baseline in Waist Circumference, LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time., Baseline, Week 26|Number of Participants With Anti-Drug Antibodies, Number of Participants With Anti-Drug Antibodies., Baseline through Week 30|Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide, Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide, Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12
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| Locations: |
Internal Medicine Center LLC, Mobile, Alabama, 36608, United States|Anaheim Clinical Trails, Anaheim, California, 92801, United States|Valley Research, Fresno, California, 93720, United States|National Research Institute, Huntington Park, California, 90255, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, Montclair, California, 91763, United States|Valley Clinical Trails, Inc, Northridge, California, 91325, United States|Artemis Institute For Clinical Research, San Diego, California, 92103, United States|Artemis Institute For Clinical Research, San Marcos, California, 92078, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|University Clinical Investigators INC, Tustin, California, 92780, United States|Chase Medical Research, Waterbury, Connecticut, 06708, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|East Coast Institute For Research, Jacksonville, Florida, 32216, United States|Suncoast Research Group, LCC, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33175, United States|Sensible Healthcare, Ocoee, Florida, 34761, United States|Palm Harbor Medical Associate, Palm Harbor, Florida, 34684, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Iderc P.L.C., West Des Moines, Iowa, 50265, United States|Cotton O'Neil Diabetes and Endocrine, Topeka, Kansas, 66606, United States|ActivMed Practices & Research, Methuen, Massachusetts, 01844, United States|Clinical Research Professionals, Saint Louis, Missouri, 63141, United States|Palm Research Center, Las Vegas, Nevada, 89128, United States|Premier Research, Trenton, New Jersey, 08611, United States|Manhattan Medical Research, New York, New York, 10016, United States|Lillestol Research LLC, Fargo, North Dakota, 58103, United States|Aventiv Research, Columbus, Ohio, 43213, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|PMG Research Of Charleston LLC, Moncks Corner, South Carolina, 29461, United States|New Phase Research & Development, Knoxville, Tennessee, 37909, United States|PMG Research Of Knoxville, Knoxville, Tennessee, 37938, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Gdańsk, 80-546, Poland|"For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.", Gdynia, 81-553, Poland|For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Gdynia, 81-553, Poland|For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Katowice, 40-772, Poland|For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Szczecin, 70-506, Poland|Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA, Łódź, 90-242, Poland|Manati Center for Clinical Research, Manati, 00674, Puerto Rico|Clinical Research Puerto Rico. Inc, San Juan, 00909, Puerto Rico|GCM Medical Group PSC, San Juan, 00909, Puerto Rico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Košice, 04012, Slovakia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Malacky, 90101, Slovakia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Púchov, 02001, Slovakia|"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.", Trenčín, 91101, Slovakia|For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Trenčín, 91101, Slovakia
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