Trial · NCT01544309
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level | Baseline, and 12 months after administration | Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months. | Percent change | MEAN |
| PRIMARY | Change in HbA1c Level | Baseline, 12 months after administration | Participants in FAS except the ones who had no HbA1c data at 12 months. | Amount of change (%) | MEAN |
| SECONDARY | Occurrence of Deterioration of Diabetic Treatment Status | Baseline, 12 months after administration | Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs. | Participants | NUMBER |
| SECONDARY | Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status | Baseline, 3, 6, 12 months after administration | Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs. | participants | NUMBER |
| SECONDARY | Percent Change in 1,5-AG Level | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） | Participants in FAS except the ones who had no 1,5-AG data at 12 months. | Percent change | MEAN |
| SECONDARY | Change in HbA1c Level | Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） | Full analysis set - All participants who received at least 1 dose of open-label study drug. | Amount of change (%) | MEAN |
| SECONDARY | Percent Change in Blood Glucose Level (Fasting) | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） | Participants in FAS except the ones who had no blood glucose level data at 12 months. | Percent change | MEAN |
| SECONDARY | Change in Blood Glucose Level (Fasting) | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） | mg/dL | MEAN | |
| SECONDARY | Percent Change in Insulin Level | Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） | Full analysis set - All participants who received at least 1 dose of open-label study drug | Percent change | MEAN |
| SECONDARY | Change From Baseline in Insulin Level | Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status） | Full analysis set - All participants who received at least 1 dose of open-label study drug. | μU/mL | MEAN |
| SECONDARY | Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) | From the start of the treatment to the end of study treatment | Number of patients with any events | NUMBER | |
| SECONDARY | Frequency of Serious Adverse Events (SAE) | Up to 12 months | Number of patients with SAE | NUMBER | |
| SECONDARY | Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) | Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment | Participants in FAS except the ones who had no lipids level data at 12 months. | Percent change | MEAN |
| SECONDARY | Percent Change in Non-HDL-C Level | Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment | Participants in FAS except the ones who had no non-HDL-C level data at 12 months. | Percent change | MEAN |
| SECONDARY | Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation | Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment | |||
| SECONDARY | Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 | 3 months after administration, the end of starting dose and the end of study treatment | Full analysis set except participants who have reached the target LDL-C level specified at the treatment start | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 1,5-AG Level | Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status） | μg/mL | 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/NCT01544309/outcomes