Trial · NCT03596450
Outcomes69
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 69
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage-point of HbA1c | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage-point of HbA1c | MEAN |
| SECONDARY | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | At year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Pounds (lbs) | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage change in body weight | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Millimeters of mercury (mmHg) | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | mmHg | MEAN |
| SECONDARY | Time to First Study Drug Discontinuation During 2 Years | Week 0 to year 2 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Years | MEAN |
| SECONDARY | Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years | Week 0 to year 2 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Years | MEAN |
| SECONDARY | Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study | Week 0 to year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage of MPR | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. | Episodes | NUMBER |
| SECONDARY | Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1 | At year 1 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for DTSQ at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not. | Scores on a scale | MEAN |
| SECONDARY | DTSQc, Total Treatment Satisfaction Score Measured at Year 2 | At year 2 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for DTSQ at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not. | Scores on a scale | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not. | Scores on a scale | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not. | Scores on a scale | MEAN |
| 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 | FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not. | Scores on a scale | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03596450/outcomes