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Trial · NCT06083675

Registered outcomes45

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in glycated haemoglobin (HbA1c)From randomisation (week 0) to week 52Measured in Percentage (%)-points.
SecondaryChange in body weightFrom randomisation (week 0) to week 52Measured in kilograms (kg).
SecondaryChange in fasting plasma glucose (FPG)From randomisation (week 0) to week 52Measured in millimoles per liter (mmol/L).
SecondaryChange in 7 point self measured plasma glucose (SMPG) mean profileFrom randomisation (week 0) to week 52Measured in mmol/L.
SecondaryChange in 7-point self-measured plasma glucose (SMPG) mean post prandial incrementsFrom randomisation (week 0) to week 52Measured in mmol/L.
SecondaryRelative change in body weightFrom randomisation (week 0) to week 52Measured in Percentage (%).
SecondaryChange in waist circumferenceFrom randomisation (week 0) to week 52Measured in centimeters (cm).
SecondaryHbA1c less than or equal to (≤) 6.5% (Yes/No)At week 52Measured as count of participants.
SecondaryHbA1c less than (<) 7% (Yes/No)At week 52Measured as count of participants.
SecondaryBody weight reduction greater than equal to ( ≥) 5% (Yes/No)At week 52Measured as count of participants.
SecondaryBody weight reduction ≥10% (Yes/No)At week 52Measured as count of participants.
SecondaryBody weight reduction ≥15% (Yes/No)At week 52Measured as count of participants.
SecondaryHbA1c <7.0% and body weight reduction ≥5% (Yes/No)At week 52Measured as count of participants.
SecondaryChange in systolic blood pressureFrom randomisation (week 0) to week 52Measured in millimeters of mercury (mmHg).
SecondaryChange in diastolic blood pressureFrom randomisation (week 0) to week 52Measured in mmHg.
SecondaryChange in High-sensitivity C-reactive protein (hsCRP)From randomisation (week 0) to week 52Measured in milligrams per liter (mg/L).
SecondaryTime to rescue medicationFrom randomisation (week 0) to week 104Measured in days.
SecondaryChange in HbA1cFrom randomisation (week 0) to week 104Measured in %-points.
SecondaryChange in body weightFrom randomisation (week 0) to week 104Measured in kg.
SecondaryChange in FPGFrom randomisation (week 0) to week 104Measured in mmol/L.

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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