Trial · NCT02451137
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia | Baseline to Month 6 | Analysis was performed on Intent-to-Treat (ITT) population which comprised of all randomized participants, irrespective of the treatment actually received, and analyzed according to the treatment group allocated by randomization. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HbA1c at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on ITT population. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Persistence Measured by Medication Possession Ratio (MPR) | At Month 6 and Month 12 | Analysis was performed on safety population. | Medication Possession ratio | MEAN |
| SECONDARY | Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period | Baseline to Month 6 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period | Baseline to Month 12 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on ITT population. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on ITT population. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Unit/kg (U/kg) | MEAN |
| SECONDARY | Percentage of Responders (Participants and Provider) Who Reported Excellent or Good Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12 | At Month 6, Month 12 | Analysis was performed on ITT population. | percentage of responders | NUMBER |
| SECONDARY | Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12 | At Baseline, Month 6, Month 12 | Analysis was performed on ITT population. Here, number analyzed = participants with available data for each specified category. | score on a scale | MEAN |
| SECONDARY | Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12 | At Month 12 | Analysis was performed on ITT population. Here, number analyzed = participants with available data for assessment during the 12 month randomized period. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 | From Baseline to Month 6 and Month 12 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period | Up to Month 6 and Month 12 | Analysis was performed on safety population. | percentage of participants | NUMBER |
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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GET https://conductscience.org/api/trials/v1/NCT02451137/outcomes