| Outcome Measures: |
Primary: Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No), Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 1; No: number of participants who did not achieve HbA1c less than 7.0 % at year 1., At year 1 | Secondary: Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1, Change in HbA1c from baseline to year 1 is presented in %-point., Baseline (less than or equal to 90 days prior to randomization at week 0), year 1|Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No), Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 2; No: number of participants who did not achieve HbA1c less than 7.0 % at year 2., At year 2|Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2, Change in HbA1c from baseline to year 2 is presented in percentage-point., Baseline (less than or equal to 90 days prior to randomization at week 0), year 2|Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No), Number of participants who attained individualized HbA1c target at year 1 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 1; No: number of participants who did not achieve individualized HbA1c target attained at year 1, At year 1|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1, At year 1|Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No), Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 1 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 1; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 1, At year 1|Change in Body Weight (in Pounds) From Baseline to Year 1, Change in body weight (in pounds) from baseline to year 1 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Percentage Change in Body Weight From Baseline to Year 1, Percentage change in body weight from baseline to year 1 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change in Systolic Blood Pressure (SBP) From Baseline to Year 1, Change in SBP from baseline to year 1 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1, Change in DBP from baseline to year 1 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Time to First Study Drug Discontinuation During 2 Years, Time to first study drug discontinuation during 2 years is presented. First study drug discontinuation=date of the first time a patient is not taking study drug as defined., Week 0 to year 2|Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years, Time to first treatment intensification (add-on) or change (switch) after randomization during 2 years is presented., Week 0 to year 2|Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study, Percentage of MPR for study drug medication adherence for the first year of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment., Week 0 to year 1|Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2, Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter from baseline to year 2 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1, DTSQc total treatment satisfaction score measured at year 1 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction., At year 1|DTSQc, Total Treatment Satisfaction Score Measured at Year 2, DTSQc total treatment satisfaction score measured at year 2 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction., At year 2|Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1, Change from baseline in SF-12 v2, PCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change From Baseline in SF-12 v2, PCS-12 Score at Year 2, Change from baseline in SF-12 v2, PCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1, Change from baseline in SF-12 v2, MCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change From Baseline in SF-12 v2, MCS-12 Score at Year 2, Change from baseline in SF-12 v2, MCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1, Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2, Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1, Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2, Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1, Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2, Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change From Baseline in WPAI-GH Activity Impairment Score at Year 1, Change from baseline in WPAI-GH activity impairment score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1|Change From Baseline in WPAI-GH Activity Impairment Score at Year 2, Change from baseline in WPAI-GH activity impairment score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health)., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2, All cause healthcare resource utilization - mean number of inpatient admissions per participant from baseline to year 2 is presented., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2, All cause HCRU - mean cumulative length of stay for inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all inpatient admissions a participant experiences from baseline to year 2., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2, All cause HCRU - mean number of emergency room (ER) encounters per participant from baseline to year 2 is presented., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2, All cause HCRU - mean number of outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2, All cause HCRU - mean number of medication visits per participant from baseline to year 2 is presented., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2, All cause HCRU - number of participants with inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced inpatient admission; no: number of participants who did not experience inpatient admission., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2, All cause HCRU - number of participants with ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced ER Encounter; no: number of participants who did not experience ER Encounter., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2, All cause HCRU - number of participants with outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced outpatient encounter; no: number of participants who did not experience outpatient encounter., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2, Diabetes related HCRU - mean number of diabetes related inpatient admissions per participant from baseline to year 2 is presented., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2, Diabetes related HCRU - mean cumulative length of stay for diabetes related inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all diabetes related inpatient admissions a participant experiences from baseline to year 2., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2, Diabetes related HCRU - mean number of diabetes related ER encounters per participant from baseline to year 2 is presented., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2, Diabetes related HCRU - mean number of diabetes related outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2, Diabetes related HCRU - mean number of diabetes related medication visits per participant from baseline to year 2 is presented., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2, Diabeted related HCRU - number of participants with diabetes related inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced diabetes related inpatient admission; no: number of participants who did not experience diabetes related inpatient admission., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2, Diabeted related HCRU - number of participants with diabeted related ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced diabeted related ER encounter; no: number of participants who did not experience diabeted related ER encounter., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2, Diabeted related HCRU - number of participants with diabeted related outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced diabeted related outpatient encounter; no: number of participants who did not experience diabeted related outpatient encounter., From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2|Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No), Number of participants who attained individualized HbA1c target at year 2 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 2; No: number of participants who did not achieve individualized HbA1c target attained at year 2, At year 2|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2., At year 2|Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No), Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1., At year 1|Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No), Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2., At year 2|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1., At year 1|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2., At year 2|Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No), Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 2 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 2; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 2., At year 2|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline., At year 1|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline., At year 2|Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No), Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline, At year 1|Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No), Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline., At year 2|Percentage Change in Body Weight From Baseline to Year 2, Percentage change in body weight from baseline to year 2 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change in Body Weight (in Pounds) From Baseline to Year 2, Change in body weight (in pounds) from baseline to year 2 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change in Systolic Blood Pressure (SBP) From Baseline to Year 2, Change in SBP from baseline to year 2 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2, Change in DBP from baseline to year 2 is presented., Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2|Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No), Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 1., Week 0 to year 1|Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No), Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 2., Week 0 to year 2|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1, At year 1|Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No), Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1., At year 1|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2., At year 2|Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No), Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2., At year 2|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1., At year 1|Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No), Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2., At year 2|Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study, Percentage of MPR for study drug medication adherence for the two years of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment., Week 0 to year 2
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| Locations: |
American Clinical Trials, Buena Park, California, 90620, United States|St. Jos Heritage Hlthcr_Fllrtn, Fullerton, California, 92835, United States|SC Clinical Research, Inc., Garden Grove, California, 92844, United States|New Hope Consulting & Clinical Trials, Lancaster, California, 93534, United States|OM Research LLC, Lancaster, California, 93534, United States|Pacific Clinical Studies, Los Alamitos, California, 90720, United States|Pacific Medical Center, Milpitas, California, 95035, United States|Facey Medical Foundation, Mission Hills, California, 91345, United States|Monterey Endocrine & Diabetes Institute, Inc, Monterey, California, 93940, United States|Do-Eun Lee, Napa, California, 94558, United States|Format Medical Research, Oxnard, California, 93030, United States|Joselito C Cabaccan, MD, San Jose, California, 95148, United States|Premier Medical Center, Inc., Toluca Lake, California, 91602, United States|Adnab Research/Prestige Care Physician, Torrance, California, 90505, United States|Altura Centers For Health, Tulare, California, 93274, United States|Tariq Javed, MD Inc., Visalia, California, 93291, United States|Endocrinology & Diabetes Specialists, Walnut Creek, California, 94598, United States|University of Colorado Hospital, Denver, Colorado, 80220, United States|Denver Endocrinology Diabetes and Thyroid Center, Englewood, Colorado, 80113, United States|ProHealth Physicians/OptumCare, Bristol, Connecticut, 06010, United States|Western Connecticut Health Network_Danbury, Danbury, Connecticut, 06810, United States|Endocrine Associates of Connecticut, Hamden, Connecticut, 06517, United States|Ismail Tarkhan MD, Milford, Connecticut, 06460, United States|Steven L. Saunders MD LLC, Milford, Connecticut, 06460, United States|The Kaufmann Clinic, Inc., Atlanta, Georgia, 30106, United States|Primary Care Research, Atlanta, Georgia, 30312, United States|Southern Family Medical Center, Augusta, Georgia, 04915, United States|River Birch Research Alliance, LLC, Blue Ridge, Georgia, 30513, United States|Gwinnett Research Insti/Buford Family Pract Urgent Care Ctr, Buford, Georgia, 30519, United States|Centricity Research, Columbus, Georgia, 31904, United States|Medical Care of LaGrange, LaGrange, Georgia, 30240, United States|Beaver Ruin Primary Care, Lilburn, Georgia, 30047, United States|Privia Medical Group of Georgia LLC, Locust Grove, Georgia, 30248, United States|DC Research Works, Marietta, Georgia, 30060, United States|Urban Family Practice Assoc, Marietta, Georgia, 30067, United States|Atlanta Center for Clinical Research, Roswell, Georgia, 30075, United States|Sandersville Family Practice, Sandersville, Georgia, 31082, United States|Meridian Clin Res, LLC, Savannah, Georgia, 31406, United States|Family Health Care Center, Statesboro, Georgia, 30461, United States|Eagles Landing Diabetes/Endocrinology, Stockbridge, Georgia, 30281, United States|Herman Clinical Research LLC, Suwanee, Georgia, 30024, United States|Sugarloaf Medical, PC, Suwanee, Georgia, 30024, United States|East Georgia Healthcare Center Inc, Swainsboro, Georgia, 30401, United States|Coastal Care Medical Clinic, Waycross, Georgia, 31501, United States|St. Vincent Research Institute, Anderson, Indiana, 46016, United States|American Health Network of Indiana, LLC_Avon_0, Avon, Indiana, 46123, United States|Adams County Family Physicians, Berne, Indiana, 46711, United States|Deaconess Clinic, Inc., Evansville, Indiana, 47725, United States|Associated Surgeons & Physicians LLC, Fort Wayne, Indiana, 46825, United States|American Health Network of IN LLC_Franklin, Franklin, Indiana, 46131, United States|American Health Network of Indiana, LLC_Greenfield, Greenfield, Indiana, 46140, United States|La Porte County Institute For Clinical Research, Michigan City, Indiana, 46360, United States|Beacon Medical Group Swartz-Weikamp, Mishawaka, Indiana, 46544, United States|American Health Network of IN LLC, Muncie, Indiana, 47304, United States|American Health Network of Indiana, LLC, New Albany, Indiana, 47150, United States|Reid Endocrinology Center, Richmond, Indiana, 47374, United States|Regional Endorine and Diabetes Associates, Ashland, Kentucky, 41101, United States|Tri State Primary Caregrayson Health Park, Ashland, Kentucky, 41101, United States|St Elizabeth Physicians Heart, Covington, Kentucky, 41011, United States|The Endocrine & Diabetes Center, Owensboro, Kentucky, 42303, United States|Paris Family Physicians PLLC, Paris, Kentucky, 40361, United States|Gaurang B. Shah, MD, Richmond, Kentucky, 40475, United States|WCMP Family Medicine, Belfast, Maine, 04915, United States|Tri-County Research, Inc., Sterling Heights, Michigan, 48310-3503, United States|Diabetes & Endo Specialists Inc, Chesterfield, Missouri, 63017, United States|University Of Missouri - Columbia, Columbia, Missouri, 65201, United States|Jefferson City Medical Group, PC, Jefferson City, Missouri, 65109, United States|Saint Louis University, Saint Louis, Missouri, 63104, United States|South County Endocrinology and Obesity Medicine, LLC, Saint Louis, Missouri, 63128, United States|Trinity Healthcare, Springfield, Missouri, 65803, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89148, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Prominis Medical Services PC, Brooklyn, New York, 11221, United States|Northwell Health Div of Endo, Great Neck, New York, 11021, United States|Advanced Internal Medicine Group, Great Neck, New York, 11023, United States|NYC Research, Inc., New York, New York, 10016, United States|NYU Grossman School of Med, New York, New York, 10016, United States|EDOC LLP, Yonkers, New York, 10704, United States|OnSite Clinical Solutions, LLC_Charlotte_0, Charlotte, North Carolina, 28210, United States|OnSite Clinical Solutions, LLC_Charlotte, Charlotte, North Carolina, 28277, United States|Valley Weight Loss Clinic, Fargo, North Dakota, 58104, United States|Catherine LaRuffa, M.D., Inc., Blanchester, Ohio, 45107, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|Medical Frontiers, LLC, Carlisle, Ohio, 45005, United States|University Hospitals of Cleveland Case Medical Center, Cleveland, Ohio, 44106, United States|Central Ohio Clinical Research LLC, Columbus, Ohio, 43213, United States|Centricity Research, Columbus, Ohio, 43213, United States|Franklin Family Practice, Franklin, Ohio, 45005, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Functional Endocrinology, Mason, Ohio, 45040, United States|New Venture Medical Research, Wadsworth, Ohio, 44281, United States|Harleysville Medical Associates, Harleysville, Pennsylvania, 19438, United States|Primary Care Research South, Inc, McMurray, Pennsylvania, 15317, United States|Preferred Primary Care Physicians_Pittsburgh, Pittsburgh, Pennsylvania, 15236, United States|Athens Medical Group, Athens, Tennessee, 37303, United States|PMG Research of Bristol, Bristol, Tennessee, 24201, United States|Murphy Research Center, Humboldt, Tennessee, 38343, United States|Ascend Research Centers, Inc., McMinnville, Tennessee, 37110, United States|Christus Trinity Clinic Hill Country Landa, New Braunfels, Texas, 78130, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|The Endocrinology Group, Arlington, Virginia, 22205, United States|Chatham Family Medical Center, Chatham, Virginia, 24531, United States|Swift Creek Family Care, Colonial Heights, Virginia, 23834, United States|Lawson Family Medicine & Aesthetics, Daleville, Virginia, 23083, United States|Privia Medical Group LLC, Danville, Virginia, 24541, United States|Seven Corners Medical, Falls Church, Virginia, 22044, United States|Hampton Family Practice, Hampton, Virginia, 23666, United States|Medical Associates of Central Virginia, Inc., Lynchburg, Virginia, 24501, United States|C. Lee Ginsburgh, Newport News, Virginia, 23606, United States|Family Medicine Healthcare, Portsmouth, Virginia, 23701, United States|Family Health Clinic, Radford, Virginia, 24141, United States|Halifax Internal Medicine, South Boston, Virginia, 24592, United States|Hampton Roads Center for Clinical Research, Suffolk, Virginia, 23435, United States|Endocrinology Consultants, Virginia Beach, Virginia, 23454, United States|Corporation Lane Research Center, Virginia Beach, Virginia, 23462, United States|Piedmont Family Practice PLC, Warrenton, Virginia, 20186, United States|Family Care of Williamsburg, Williamsburg, Virginia, 49820, United States|St. Vincent Hosp-Prevea Health, Green Bay, Wisconsin, 54303, United States|Ascension Medical Group- Germantown Clinic, Milwaukee, Wisconsin, 53211, United States|Medical College of Wisconsin & Zablocki VAMC, Milwaukee, Wisconsin, 53226, United States|Western University Medical Center at WU of Health Sciences, London, Ontario, N6G 2M1, Canada
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