Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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 |
|
| Secondary |
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 (Yes/No) |
|
At year 2 |
|
| Secondary |
Change in HbA1c (%-Point) From Baseline to Year 2 |
|
Baseline (less than or equal to 90 days prior to randomization at week 0), year 2 |
|
| Secondary |
Number of Participants With Individualized HbA1c Target Attained at Year 1 (Yes/No) |
Number of participants who achieved individualized HbA1c target attained 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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
Time to First Study Drug Discontinuation During 2 Years |
|
Week 0 to year 2 |
|
| Secondary |
Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years |
|
Week 0 to year 2 |
|
| Secondary |
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 |
|
| Secondary |
Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
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 |
|
| Secondary |
DTSQc, Total Treatment Satisfaction Score Measured at Year 2 |
|
At year 2 |
|
| Secondary |
Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Summary Component (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 summary component (PCS) Score and Mental summary component (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 |
|
| Secondary |
Change From Baseline in SF-12 v2, PCS-12 Score at Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
Change From Baseline in SF-12 v2, Mental Summary Component (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 |
|
| Secondary |
Change From Baseline in SF-12 v2, MCS-12 Score at Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
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 |
|
| Secondary |
Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
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 |
|
| Secondary |
Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
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 |
|
| Secondary |
Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
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 |
|
| Secondary |
Change From Baseline in WPAI-GH Activity Impairment Score at Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
All Cause Healthcare Resource Utilization (HCRU): Number of Inpatient Admissions From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Cumulative Length of Stay for Inpatient Admissions From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Number of Emergency Room (ER) Encounters From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Number of Outpatient Encounters From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Number of Medications From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Occurrence of Inpatient Admission (Yes/No) From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Occurrence of ER Encounter (Yes/No) From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
All Cause HCRU: Occurrence of Outpatient Encounter (Yes/No) From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Number of Diabetes Related Inpatient Admissions From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Cumulative Length of Stay for Diabetes Related Inpatient Admissions From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Number of Diabetes Related ER Encounters From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Number of Diabetes Related Outpatient Encounters From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Number of Diabetes Related Medications From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Occurrence of Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Occurrence of Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Diabetes Related HCRU: Occurrence of Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 |
|
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 |
|
| Secondary |
Number of Participants With Individualized HbA1c Target Attained at Year 2 (Yes/No) |
|
At year 2 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
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 |
|
| Secondary |
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) |
|
At year 2 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) |
|
At year 2 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
Change in Body Weight (in Percentage) From Baseline to Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
Change in Body Weight (in Pounds) From Baseline to Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
Change in SBP From Baseline to Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
Change in DBP From Baseline to Year 2 |
|
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 |
|
| Secondary |
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 |
|
| Secondary |
Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) |
|
Week 0 to year 2 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
At year 2 |
|
| Secondary |
Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study |
|
Week 0 to year 2 |
|
