Trial · NCT03596450
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 69
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | At year 1 | 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. |
| Secondary | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 1 | Change in HbA1c from baseline to year 1 is presented in %-point. |
| Secondary | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | At year 2 | 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. |
| Secondary | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 2 | Change in HbA1c from baseline to year 2 is presented in percentage-point. |
| Secondary | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | At year 1 | 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 |
| 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) | At year 1 | 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 |
| Secondary | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | At year 1 | 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 |
| Secondary | Change in Body Weight (in Pounds) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in body weight (in pounds) from baseline to year 1 is presented. |
| Secondary | Percentage Change in Body Weight From Baseline to Year 1 | 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 is presented. |
| Secondary | Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in SBP from baseline to year 1 is presented. |
| Secondary | Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in DBP from baseline to year 1 is presented. |
| Secondary | Time to First Study Drug Discontinuation During 2 Years | Week 0 to year 2 | 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. |
| Secondary | Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years | Week 0 to year 2 | Time to first treatment intensification (add-on) or change (switch) after randomization during 2 years is presented. |
| Secondary | Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study | Week 0 to year 1 | 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. |
| 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 | Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter from baseline to year 2 is presented. |
| Secondary | Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1 | 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. |
| Secondary | DTSQc, Total Treatment Satisfaction Score Measured at Year 2 | 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. |
| Secondary | Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1 | 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 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. |
| 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 | 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. |
| Secondary | Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1 | 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 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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