Trial · NCT01243424
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The First 3-point Major Adverse Cardiovascular Events (3P-MACE) | From randomization until individual day of trial completion, up to 432 weeks | The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented. |
| Secondary | The First 4-point (4P)- MACE | From randomization until individual day of trial completion, up to 432 weeks | The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris. |
| Secondary | Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase | From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) | The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without \>2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase. |
| Secondary | Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase | From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) | The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without \>2% weight gain during maintenance phase. |
| Secondary | Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE | From randomization until individual day of trial completion, up to 432 weeks | Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint. |
| Secondary | Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE | From randomization until individual day of trial completion, up to 432 weeks | Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint. |
| Secondary | Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events | From start of the treatment until 7 days after the end of treatment, up to 433 weeks | Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: * CV death (including fatal stroke and fatal MI) * non-fatal MI * non-fatal stroke * hospitalisation for unstable angina pectoris * TIA * hospitalisation for heart failure * hospitalisation for coronary revascularisation procedures (CABG, PCI) |
| Secondary | Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events | From start of the treatment until 7 days after the end of treatment, up to 433 weeks | Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: * CV death (including fatal stroke and fatal MI) * non-fatal MI * non-fatal stroke * hospitalisation for unstable angina pectoris * Transient ischaemic attack (TIA) * hospitalisation for heart failure * hospitalisation for coronary revascularisation procedures (CABG, PCI) |
| Secondary | Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c) | Baseline and week 432 | Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) | Baseline and week 432 | Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol | Baseline and week 432 | Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit in Triglycerides | Baseline and week 432 | Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit in Creatinine | Baseline and week 432 | Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR) | Baseline and week 432 | Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR) | Baseline and week 432 | Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Percentage of Participants With Transition in Albuminuria Classes | Baseline and week 432 | Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented. |
| Secondary | Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks | Baseline and week 208 | The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint. |
| Secondary | Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up | 433 weeks | Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint. |
| Secondary | Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study | Baseline | Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint. |
| Secondary | CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study | Baseline | Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint. |
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.
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