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Trial · NCT00819741

Outcomes15

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Glycosylated Haemoglobin A1c (HbA1c)week -2 (screening), week 16Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.percentage (%) of total haemoglobinLEAST_SQUARES_MEAN
SECONDARYChange in Fasting Plasma Glucoseweek 0, week 16Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.mmol/LLEAST_SQUARES_MEAN
SECONDARYChange in 2-hour Postprandial Plasma GlucoseWeek 0, week 16Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.mmol/LLEAST_SQUARES_MEAN
SECONDARYChange in 7-point Plasma Glucose ProfileWeek 0, week 16Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.mmol/LLEAST_SQUARES_MEAN
SECONDARYChange in Fasting Serum InsulinWeek 0, week 16
Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
mU/LLEAST_SQUARES_MEAN
SECONDARYChange in 2-hour Postprandial Serum InsulinWeek 0, week 16
Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
mU/LLEAST_SQUARES_MEAN
SECONDARYChange in Fasting Serum C-peptideWeek 0, week 16
Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
ng/mlLEAST_SQUARES_MEAN
SECONDARYChange in 2-hour Postprandial Serum C-peptideWeek 0, week 16
Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
ng/mlLEAST_SQUARES_MEAN
SECONDARYHypoglycaemic EpisodesWeeks 0-16Safety analysis set was defined as all randomised and exposed subjects.episodesNUMBER
SECONDARYChange in Blood PressureWeek 0, week 16Safety analysis set was defined as all randomised and exposed subjects.mmHgMEAN
SECONDARYPhysical ExaminationsWeek -2, week 16Safety analysis set was defined as all randomised and exposed subjects.SubjectsNUMBER
SECONDARYECG (ElectroCardioGram)Week -2, week 16Safety analysis set was defined as all randomised and exposed subjects.SubjectsNUMBER
SECONDARYBiochemistry: Alanine Aminotransferase (ALAT)Week -2, week 16Safety analysis set was defined as all randomised and exposed subjects.SubjectsNUMBER
SECONDARYBiochemistry: Alanine Aminotransferase (ASAT)Week -2, week 16Safety analysis set was defined as all randomised and exposed subjects.SubjectsNUMBER
SECONDARYHaematology: HaemoglobinWeek -2, week 16Safety analysis set was defined as all randomised and exposed subjects.SubjectsNUMBER

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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