| Outcome Measures: |
Primary: Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables., Baseline, Week 12 | Secondary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12, LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12, LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12, LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12, LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12, iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from Glucose measures taken every 15 minutes from 0 to 1 hour after meal using CGM sensor (i.e., 0, 15, 30, 45, 60 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate., Baseline, Week 12|Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12, iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from glucose measures taken every 15 minutes from 0 to 2 hours after meal using CGM sensor (i.e., 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate., Baseline, Week 12|Percentage of Participants With HbA1c <7% and ≤6.5%, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time., Week 12|Change From Baseline in Daily Insulin Dose at Week 12, LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12, LS mean was determined by MMRM model with Baseline + Time as variables., Baseline, Week 12|Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12, The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for subjects taking insulin under 5 domains: Inconvenience of Regimen \[IR - 5 items\], Lifestyle Flexibility \[LF - 3 items\], Glycemic Control \[GC - 3 items\], Hypoglycemic Control \[HC - 5 items\], Insulin Delivery Device \[IDD - 6 items\]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. Data presented are for Glycemic Control Domain Scores transformed on a 0-100 scale, where transformed domain score = 100×\[(7-raw domain score)/6\]. Higher scores indicate better glycemic control. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as a covariate., Baseline, Week 12
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| Locations: |
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|AMCR Institute, Escondido, California, 92025, United States|Valley Endocrine, Fresno, Fresno, California, 93720, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Coastal Metabolic Research Centre, Ventura, California, 93003, United States|CMR of Greater New Haven, Hamden, Connecticut, 06517, United States|Encore Medical Research, Hollywood, Florida, 33021, United States|Sun Coast Clinical Research, Inc, New Port Richey, Florida, 34652, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|East Coast Institute for Research at The Jones Center, Macon, Georgia, 31210, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative, Springfield, Illinois, 62711, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Maryland Cardiovascular Specialists, Baltimore, Maryland, 21229, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89148, United States|Research NYC, Inc, New York, New York, 10016, United States|Suny Health Science Center at Syracuse, Syracuse, New York, 13210, United States|Cataret Medical Group, Morehead City, North Carolina, 28557, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78749, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Biopharma Informatic, LLC, Houston, Texas, 77043, United States|Endocrine Ips, Pllc, Houston, Texas, 77079, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Burke Internal Medicine and Research, Burke, Virginia, 22015, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Advanced Clinical Research, LLC, Bayamon, 00961, Puerto Rico|Manati Center for Clinical Research Inc, Manati, 00674, Puerto Rico
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