Trial · NCT01544309
LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts
NCT01544309, Not applicable, Completed, Listen Trial Group; results first posted 2015-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts. Trials, record NCT01544309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01544309
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts
- NCT number
- NCT01544309
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,049 participants, actual
- Lead sponsor
- Listen Trial Group
- Conditions
- Hypercholesterolemia With Concomitant Type 2 Diabetes
- Interventions
- Atorvastatin, Rosuvastatin
- First posted
- 2012-03-05
- Last updated
- 2015-03-17
- Results first posted
- 2015-03-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level | Atorvastatin Administration Group | -31.3 | Standard Deviation 19.1 | Percent change | |
| Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level | Rosuvastatin Administration Group | -32.8 | Standard Deviation 18.1 | Percent change | |
| Change in HbA1c Level | Atorvastatin Administration Group | 0.120 | Standard Deviation 0.65 | Amount of change (%) | |
| Change in HbA1c Level | Rosuvastatin Administration Group | 0.10 | Standard Deviation 0.67 | Amount of change (%) | |
| Occurrence of Deterioration of Diabetic Treatment Status | Atorvastatin Administration Group | Therapy intensification | 64 | Participants | |
| Occurrence of Deterioration of Diabetic Treatment Status | Rosuvastatin Administration Group | Therapy intensification | 45 | Participants | |
| Occurrence of Deterioration of Diabetic Treatment Status | Atorvastatin Administration Group | Deterioration in HbA1c of > 0.5% | 177 | Participants | |
| Occurrence of Deterioration of Diabetic Treatment Status | Rosuvastatin Administration Group | Deterioration in HbA1c of > 0.5% | 162 | Participants | |
| Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status | Atorvastatin Administration Group | Therapy intensification: 0-3 months | 20 | participants | |
| Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status | Rosuvastatin Administration Group | Therapy intensification: 0-3 months | 14 | participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin Administration Group | 524 | |
| Overall Study | STARTED | Rosuvastatin Administration Group | 525 | |
| Overall Study | COMPLETED | Atorvastatin Administration Group | 504 | |
| Overall Study | COMPLETED | Rosuvastatin Administration Group | 514 | |
| Overall Study | NOT COMPLETED | Atorvastatin Administration Group | 20 | |
| Overall Study | NOT COMPLETED | Rosuvastatin Administration Group | 11 |
Source ClinicalTrials.gov
Adverse events382
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Atorvastatin Administration Group | 13 | 506 | |
| other | Nasopharyngitis | Infections and infestations | Rosuvastatin Administration Group | 15 | 516 | |
| other | Bronchitis | Infections and infestations | Atorvastatin Administration Group | 3 | 506 | |
| other | Bronchitis | Infections and infestations | Rosuvastatin Administration Group | 3 | 516 | |
| other | Cystitis | Infections and infestations | Atorvastatin Administration Group | 1 | 506 | |
| other | Cystitis | Infections and infestations | Rosuvastatin Administration Group | 5 | 516 | |
| other | Pneumonia | Infections and infestations | Atorvastatin Administration Group | 0 | 506 | |
| other | Pneumonia | Infections and infestations | Rosuvastatin Administration Group | 2 | 516 | |
| other | Influenza | Infections and infestations | Atorvastatin Administration Group | 2 | 506 | |
| other | Influenza | Infections and infestations | Rosuvastatin Administration Group | 2 | 516 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin Administration Group | ||
| Total, all-cause mortality | Rosuvastatin Administration Group | ||
| Total, other adverse events | Atorvastatin Administration Group | 87 | 506 |
| Total, other adverse events | Rosuvastatin Administration Group | 88 | 516 |
| Total, serious adverse events | Atorvastatin Administration Group | 14 | 506 |
| Total, serious adverse events | Rosuvastatin Administration Group | 19 | 516 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25186922 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atorvastatin Administration Group vs Rosuvastatin Administration Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01544309
GET https://conductscience.org/api/trials/v1/NCT01544309/results?page=2