Trial · NCT03214367
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline HbA1c data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | milligrams per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Severe Hypoglycemia at Week 26 | Baseline through Week 26 | All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Events per 100 participant years | NUMBER |
| SECONDARY | Rate of Documented Symptomatic Hypoglycemia at Week 26 | Baseline through Week 26 | All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Events per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline 1,5-AG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | milligram per liter (mg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline SMBG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Dose at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline basal insulin dose data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Units (U)/day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26 | Baseline, Week 26 | All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26 | Baseline, Week 26 | All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the LOCF method to the post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HbA1c <7% | Week 26 | All randomized participants with baseline and at least one post-baseline HbA1c \<7% data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HbA1c at Week 52 | Baseline, Week 52 | All randomized participants with baseline and at least one postbaseline observation for HbA1c. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. Only double blind arms analysed for this outcome because open label group ended at week 26. | Percentage of HbA1c | LEAST_SQUARES_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.
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GET https://conductscience.org/api/trials/v1/NCT03214367/outcomes