| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), 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 determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction., Baseline, 26 Weeks | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG), Fasting plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction., Baseline, 26 Weeks|Percentage of Participants With HbA1c <7.0%, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Longitudinal logistic regression was used to model the likelihood of having hbA1c\<7.0% at Week 26 with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction., 26 Weeks|Percentage of Participants With HbA1c <7.5%, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Longitudinal logistic regression was used to model the likelihood of having hbA1c\<7.5% at Week 26 with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction., 26 Weeks|Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values, Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction., Baseline, 26 Weeks|Change From Baseline in Total Daily Dose (TDD), Baseline TDD was defined as the last prestudy insulin TDD prior to randomization to receiving the first dose of U-500 insulin post randomization. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction., Baseline, 26 Weeks|Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL), The percentage of participants with hypoglycemic episodes (documented hypoglycemia) was calculated by dividing the number of participants with at least 1 hypoglycemic episode (documented hypoglycemia) over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. Logistic regression was used to estimate the odds ratio between the two treatments of at least 1 hypoglycemic episode (documented hypoglycemia) over 26 week treatment period adjusted for baseline documented hypoglycemia rate, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction., 26 Weeks|Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL), Documented Hypoglycemic episodes with blood glucose\<=70mg/dL was used in this outcome measure. Hypoglycemia rate (documented hypoglycemia) per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia (documented hypoglycemia) was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline documented hypoglycemia rate, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, with log of exposure in days divided by 30 as the offset, treatment, visit, and visit by treatment interaction., Baseline to 26 Weeks|Change From Baseline in Body Weight, Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, treatment by time interaction., Baseline, 26 Weeks
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| Locations: |
Internal Medicine Center LLC, Mobile, Alabama, 36608, United States|John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Valley Endocrine, Fresno, Fresno, California, 93720, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|Diabetes and Endocrine Associates, La Mesa, California, 91942, United States|First Valley Medical Group, Lancaster, California, 93534, United States|Pacific Research Partners, LLC, Oakland, California, 94607, United States|Inland Empire Liver Foundation, Rialto, California, 92377, United States|NorCal Endocrinology and Internal Medicine - Roseville, Roseville, California, 95661, United States|NorCal Endocrinology and Internal Medicine - Roseville, San Ramon, California, 94583, United States|Olive View Medical Center, Sylmar, California, 91342, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|East Coast Institute For Research, LLC, Jacksonville, Florida, 32216, United States|Suncoast Clinical Research, New Port Richey, Florida, 34652, United States|Metabolic Research Institute Inc., West Palm Beach, Florida, 33401, United States|East Coast Institute For Research, LLC, Macon, Georgia, 31210, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|John H. Stroger Hospital of Cook County, Chicago, Illinois, 60612, United States|Midwest CRC, Crystal Lake, Illinois, 60012, United States|HSHS Medical Group Diabetes Research, Springfield, Illinois, 62711, United States|Iderc, P.L.C., Des Moines, Iowa, 50314, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|Kentucky Diabetes Endocrinology Center, Lexington, Kentucky, 40503, United States|The Arthritis & Diabetes Clinic Inc., Monroe, Louisiana, 71203, United States|Grunberger Diabetes Institute, Bloomfield Hills, Michigan, 48302, United States|Adult Endocrinology Consultants, P.C., Livonia, Michigan, 48154, United States|JCMG Clinical Research, Jefferson City, Missouri, 65109, United States|Billings Clinic Research Center, Billings, Montana, 59101, United States|Diabetes and Endocrinology Associates, Omaha, Nebraska, 68114, United States|Palm Research Center, Las Vegas, Nevada, 89128, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|North Shore Diabetes and Endocrine Assoc, New Hyde Park, New York, 11040, United States|Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States|Physicians East, Greenville, North Carolina, 27834, United States|PMG Research of Rocky Mount, LLC, Rocky Mount, North Carolina, 27804, United States|University of Oklahoma Health Sciences Center-Tulsa, Oklahoma City, Oklahoma, 73104, United States|Portland Diabetes & Endocrine Center, Portland, Oregon, 97210, United States|Endocrine Metabolic Associates, P.C., Philadelphia, Pennsylvania, 19114, United States|Partners in Nephrology & Endocrinology, Pittsburgh, Pennsylvania, 15224, United States|Sudhir Bansal M.D. Inc., Warwick, Rhode Island, 02886, United States|AM Diabetes and Endocrinology Center, Bartlett, Tennessee, 38133, United States|University Diabetes and Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Vanderbilt Univeristy School of Medicine, Nashville, Tennessee, 37232, United States|Texas Diabetes and Endocrinology-Austin South, Austin, Texas, 78749, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Texas Diabetes and Endocrinology, P.A., Round Rock, Texas, 78681, United States|Advanced Research Institute, South Ogden, Utah, 84405, United States|Dr. Larry Stonesifer, Federal Way, Washington, 98003, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Northside Internal Medicine, Spokane, Washington, 99208, United States|Multicare Health System, Tacoma, Washington, 98405, United States|Dr Altagracia Aurora Alcantara Gonzalez, Bayamon, 00956, Puerto Rico|Manati Center for Clinical Research Inc, Manati, 00674, Puerto Rico|Endocrine Lipid Diabetes Research Institute, Ponce, 00717, Puerto Rico|American Telemedicine Center, San Juan, 00917, Puerto Rico|Martha Gomez Cuellar M.D., San Juan, 00921, Puerto Rico
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