Trial · NCT01243424
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The First 3-point Major Adverse Cardiovascular Events (3P-MACE) | From randomization until individual day of trial completion, up to 432 weeks | Treated set (TS): All patients treated with at least one dose of trial drug. | Events/ 1000 patients-years | NUMBER |
| SECONDARY | The First 4-point (4P)- MACE | From randomization until individual day of trial completion, up to 432 weeks | TS | Events/ 1000 patients-years | NUMBER |
| 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) | TS without duplicates (TS w/o duplicates), patients who are off-drug or died prior to regular study stop were handled as non-completers considered failure (NCF). | Percentage of participants (%) | NUMBER |
| 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) | TS w/o duplicates (NCF) | Percentage of participants (%) | NUMBER |
| 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 | TS | Percentage of participants (%) | NUMBER |
| 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 | TS | Percentage of participants (%) | NUMBER |
| 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 | TS | Percentage of participants (%) | NUMBER |
| 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 | TS | Events/ 1000 patients-years | NUMBER |
| SECONDARY | Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c) | Baseline and week 432 | TS w/o duplicates considering all available data | Percentage glycosylated hemoglobin (%) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) | Baseline and week 432 | TS w/o duplicates considering all available data | Milligram/ deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| 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 | TS w/o duplicates, participants on treatment | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Triglycerides | Baseline and week 432 | TS w/o duplicates, participants on treatment | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Creatinine | Baseline and week 432 | TS w/o duplicates, participants on treatment | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR) | Baseline and week 432 | TS w/o duplicates, participants on treatment | mL/minute/1.73 meter^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR) | Baseline and week 432 | TS w/o duplicates, participants on treatment | mg/ gcrea | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Transition in Albuminuria Classes | Baseline and week 432 | TS w/o duplicates, participants on treatment | Percentage of participants (%) | NUMBER |
| SECONDARY | Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks | Baseline and week 208 | Meal tolerance test(MTT) last observation carried forward(LOCF) set: Randomised and treated patients with one dose of study drug and signed the sub-study Informed Consent with valid baseline and on-treatment MTT. If values taken after rescue medication intake will be set to missing, last observed on-treatment value was carry forwarded. | Picomol/ minute/meter^2 (pmol/min/m²) | MEAN |
| SECONDARY | Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up | 433 weeks | Full analysis set cognition(FAS-COG): Randomised and treated patients with one dose of study drug, baseline assessment (the z-scores, A\&E or Mini-mental state examination(MMSE) can be calculated), years of formal education with baseline MMSE≥24 and at least one on-treatment assessment (of which at least one of the RBI scores can be calculated). | Percentage of participants (%) | NUMBER |
| 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 | The sub-study was stopped early and required target with an estimated time point of 432 weeks was not achieved for this endpoint. Thus the data were not unblinded and only the baseline data collected were reported overall and not by treatment arm for this endpoint. | Milligrams/ deciliter (mg/ dL) | MEAN |
| SECONDARY | CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study | Baseline | The sub-study was stopped early and required target with an estimated time point of 432 weeks was not achieved for this endpoint. Thus the data were not unblinded and only the baseline data collected were reported overall and not by treatment arm for this endpoint. | Millimoles/ Litre (mmol/L) | 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.
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GET https://conductscience.org/api/trials/v1/NCT01243424/outcomes