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Trial · NCT00379769

Outcomes53

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Cardiovascular Death/Cardiovascular Hospitalisation EventsBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYNumber of Participants With Cardiovascular Events and All-cause DeathsBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYTotal Number of Cardiovascular Hospitalisations and Cardiovascular DeathsBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationNumber of eventsNUMBER
SECONDARYNumber of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by StratumBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpartcipantsNUMBER
SECONDARYNumber of Participants With CV/Microvascular EventsBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYNumber of Participants With Glycaemic Failure EventsBaseline through to end of randomised dual therapyIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYNumber of Participants With Addition of Third Oral Agent/Switch to InsulinBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYThe Number of Participants Starting Insulin at Any Time During the StudyBaseline through End of Study (up to 7.5 years)Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYModel Adjusted Change From Baseline in HbA1c at Month 60Baseline and Month 60 of randomised dual therapy treatment periodIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationPercentMEAN
SECONDARYModel Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60Baseline to Month 60 of the randomised dual therapy treatment periodIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationmmol/L (millimoles/Liter)MEAN
SECONDARYModel Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60Baseline to Month 60 of the randomised dual therapy treatment periodIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpicamoles/liter (pmol/L)MEAN
SECONDARYNumber of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60Baseline to Month 60 of the randomised dual therapy treatment periodIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationparticipantsNUMBER
SECONDARYModel Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60Baseline to Month 60 of the randomised dual therapy treatment phaseIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpercent changeGEOMETRIC_MEAN
SECONDARY
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
Baseline to Month 60 of the randomised dual therapy treatment phaseIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpercent changeGEOMETRIC_MEAN
SECONDARY
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
Baseline to Month 60 of the randomised dual therapy treatment periodIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpercent changeGEOMETRIC_MEAN
SECONDARYModel Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60Baseline to Month 60 of the randomised dual therapy treatment periodIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpercent changeGEOMETRIC_MEAN
SECONDARYModel Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60Baseline to Month 60 of the randomised dual therapy treatment phaseIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationpercent changeGEOMETRIC_MEAN
SECONDARYModel Adjusted Change From Baseline in Body Weight at Month 60Baseline to Month 60 of the randomised dual therapy treatment phaseIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationkilogramsMEAN
SECONDARYModel Adjusted Change From Baseline in Alanine Aminotransferase at Month 60Baseline to Month 60 of the randomised dual therapy treatment phaseIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationU/L (Units/Liter)MEAN
SECONDARYModel Adjusted Change From Baseline in Waist Circumference at Month 60Baseline to Month 60 of the randomised dual therapy treatment phaseIntent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medicationcm (centimeters)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.

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