| Outcome Measures: |
Primary: Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)], The percentage of time spent in the glycemic target range of 70 to 180 mg/dL was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements. Baseline is defined as the first 14 evaluable days of evaluable continuous glucose monitoring (CGM) data prior to first day of treatment. CGM compliance is defined as 1) at least 8 out of 14 days (not necessarily consecutive) have 100% of evaluable CGM data per 24-hour period (at least 8 days with 96 records minimum per day) OR 2) at least 9 out of 14 days (not necessarily consecutive) have ≥89% of evaluable CGM data per 24-hour period (at least 9 days with 85 records minimum per day) OR 3) at least 10 out of 14 days (not necessarily consecutive) have at least ≥80% of evaluable CGM data per 24 hour period (at least 10 days with 77 records minimum per day)., Baseline (Days -14 to -1) and Week 16 | Secondary: Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV), Glucose total CV was calculated by following: standard deviation glucose/mean glucose over 14 days x 100, and the percent change was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment., Baseline (Days -14 to -1) and Week 16|Change From Baseline to Week 16 in Mean Daily Blood Glucose, A global average was computed to determine the average of the mean daily blood glucose for the 14 days at baseline and Week 16. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment., Baseline (Days -14 to -1) and Week 16|Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal, The analysis was focused on the 4-hour interval at both baseline and Week 16 from t=0 (the timepoint at which glucose measurement was taken immediately preceding liquid meal administration) throughout the subsequent 4 hours. For each participant, the overall maximum glucose value within the described 4-hour period was determined, and the difference between the maximum glucose value at baseline and Week 16 was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment., Baseline (Days -14 to -1) and Week 16|Change From Baseline to Week 16 in Time Above Range (>180 mg/dL), The time spent above the glycemic target range was calculated as 100 times the total number of 15-minute increments of CGM data where a participant's blood glucose falls above normal range (\>180 mg/dL) at baseline, divided by the total number of 15-minute increments read (i.e., up to 1344 15-minute increments) at Week 16. This was calculated for baseline and Week 16 and the change was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment., Baseline (Days -14 to -1) and Week 16|Percentage of Participants Who Achieved Coefficient of Variation <36%, Percentage of participants achieving CV \<36% was calculated as sum of the number of participants with CV \<36% divided by the total number of participants. The endpoint was calculated using all CGM glucose readings available throughout each day for 2 weeks (Week 14-16)., Week 16|Change From Baseline to Week 16 in Time in Range Per Time Blocks, Time spent in the glycemic target range (70 to 180 mg/dL) was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements per time block and comparing the corresponding time blocks from Week 16 to baseline. The time blocks are 12 am to 6 am, 6 am to 12 pm, 12 pm to 6 pm, 6 pm to 12 am, and 6 am to 12 am. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment., Baseline (Days -14 to -1) and Week 16|Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9%, The GMI was calculated as 3.31 + 0.02392 x (mean glucose in mg/dL from CGM data). The GMI was calculated by determining the number of participants who achieved \<7% and \<9% at Week 16., Week 16|Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours, Blood samples were collected to measure the glucose values up to 4-hour after the breakfast meal. The analysis was based on a liquid meal at both baseline and Week 16 (a liquid meal administered in a fasted state and blood glucose is measured at specific time points up to 4 hours). Baseline is defined as the time period prior to administration of study drug., Baseline (Days -14 to -1) and Week 16|Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration, Blood samples were collected at specific intervals over a 4 hour period to measure blood glucose values following ingestion of a liquid meal and the process is repeated after 16 weeks of study drug administration following another liquid meal administration and blood glucose values measured at specific time points over 4 hours. The difference in the time to reach the maximal blood glucose value was then calculated between these two timepoints., Baseline (Days -14 to -1) and Week 16|Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL, Blood glucose level was determined based upon CGM data. Percentage of participants with glucose level \<54 mg/dL for less than 15 minutes per day are reported., Week 16|Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire, The changes in diabetes medication treatment-related impact and satisfaction was measured by the DM-SAT. The DM-SAT is a 16-item measure with 4 domains/subscales assessing lifestyle (5 items), medical control (3 items), convenience (5 items) and well being (3 items). Each item is measured on a scale from 0-10, where 0= not at all satisfied, 1 to 3= not too satisfied, 4 to 6 = somewhat satisfied, 7-9= very satisfied and 10= extremely satisfied. The overall score was calculated as the sum of the 16 questions with a score that ranges from 0 to 160. A higher score indicates a positive result. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of administration., Baseline (Days -14 to -1) and Week 16|Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels, Hypoglycemia event is defined as any event recorded in hypoglycemic event information library electronic case report form page that has "Yes" as the response to the question "Were any hypoglycemic events experienced". American Diabetes Association (ADA) Level 1 hypoglycemia is defined as measurable glucose concentration \<70 mg/dL \[3.9 millimoles per liter (mmol/L)\] but \>=54 mg/dL (3.0 mmol/L). ADA Level 2 hypoglycemia is defined as measurable glucose concentration \<54 mg/dL (3.0 mmol/L) that needed immediate action. ADA Level 3 hypoglycemia is defined as severe event characterized by altered mental and/or physical functioning that required assistance from another person for recovery of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest. Participants might have experienced both Level 1 and 2 hypoglycemia events., From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events, An AE is any untoward medical occurrence in a participant or clinical study participant, whether or not considered related to the study drug. An SAE is defined as any AE that, at any dose, meets one of the following criteria: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or congenital anomaly/birth defect. TEAEs is defined as AEs that developed, worsened, or became serious during the treatment-emergent period, defined as the time from the first administration of the study drug (Day 1) to the last administration of the study drug + 3 days., From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)
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| Locations: |
Clearview Medical Research LLC-Site Number:8400003, Canyon Country, California, 91351-4138, United States|National Research Institute - ClinEdge - PPDS-Site Number:8400004, Huntington Park, California, 90255-2959, United States|National Research Institute - ClinEdge - PPDS-Site Number:8400009, Huntington Park, California, 90255-2959, United States|Torrance Clinical Research Institute-Site Number:8400008, Lomita, California, 90717-2101, United States|Downtown LA Research Center Inc - ClinEdge - PPDS-Site Number:8400001, Los Angeles, California, 90017-5649, United States|University Clinical Investigators Inc-Site Number:8400020, Tustin, California, 92780, United States|San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012, West Hills, California, 91304-3837, United States|Premier Research Associate-Miami-Site Number:8400002, Miami, Florida, 33165-7043, United States|Floridian Research Institute-Site Number:8400013, Miami, Florida, 33179-2537, United States|Palm Research Center, Inc.-Site Number:8400005, Las Vegas, Nevada, 89128-0463, United States|Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007, Berlin, New Jersey, 08009, United States|Mid Hudson Medical Research PLLC-Site Number:8400014, New Windsor, New York, 12553-7754, United States|Endocrinology Associates Inc-Site Number:8400011, Columbus, Ohio, 43201-3209, United States|University of Tennessee Health Science Center-Site Number:8400017, Memphis, Tennessee, 38163, United States|University of Texas Southwestern Medical Center-Site Number:8400018, Dallas, Texas, 75390, United States|Flourish Research - San Antonio - PPDS-Site Number:8400006, San Antonio, Texas, 78229-3539, United States|Northeast Clinical Research of San Antonio LLC-Site Number:8400019, Schertz, Texas, 78154, United States|Consano Clinical Research LLC-Site Number:8400010, Shavano Park, Texas, 78231-1281, United States
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