Trial · NCT01544309
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level | Baseline, and 12 months after administration | |
| Primary | Change in HbA1c Level | Baseline, 12 months after administration | |
| Secondary | Occurrence of Deterioration of Diabetic Treatment Status | Baseline, 12 months after administration | "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of \> 0.5%. |
| Secondary | Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status | Baseline, 3, 6, 12 months after administration | "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of \> 0.5%. |
| 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） | An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa |
| 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） | |
| 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） | |
| 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） | |
| 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） | An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa. |
| 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） | An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa |
| 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 | |
| Secondary | Frequency of Serious Adverse Events (SAE) | Up to 12 months | |
| 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 | |
| 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 | |
| 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 | Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP) |
| 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 | Percentage of participants achieving the target LDL-C levels \<100 mg/dL for participants with history of coronary artery diseases (CAD) and \<120 mg/dL for participants without history of CAD are presented. |
| 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） | An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa |
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/registered