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Trial · NCT02878798

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIntraepidermal Nerve Fiber Density (IENFD)96 weeksfibers/mm/year (52 weeks)LEAST_SQUARES_MEAN
PRIMARYNorfolk Quality of Life - Diabetic Neuropathy96 weeks (expressed as a slope in change of total score/52 weeks)Change inTotal NQOL-DN score over 52 wksLEAST_SQUARES_MEAN
SECONDARYBrief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference96 weeks (expressed as a change in change in pain interference/52weeks)Slope of change in BPI-DN PI over 52 wksLEAST_SQUARES_MEAN
SECONDARYBrief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity96 weeks (expressed as a slope of change over 52 weeks)Slope of change in BPI-DN pain over 52 wLEAST_SQUARES_MEAN
SECONDARYUtah Early Neuropathy Scale96 weeks (expressed as a slope of change in total UENS over 52 weeks).Slope of change in Total UENS over 52wksLEAST_SQUARES_MEAN
SECONDARYSural Sensory Amplitude (SSA)96 weeks (slope of change in mV/52weeks)slope of change in SSA uV over 52 wksLEAST_SQUARES_MEAN
SECONDARYPeroneal Motor Conduction Velocity (PMCV)96 weeks (expressed as a slope of change in meter/sec over 52 weeks)Slope of change in M/S over 52 wksLEAST_SQUARES_MEAN
SECONDARYBody Mass Index (BMI)96 weeks (slope of change in kg/m2/52 weeks)Slope of change in BMI kg/m2 over 52wksLEAST_SQUARES_MEAN
SECONDARYHemoglobin A1CThe annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weekschange in %/52 weeks over 96 weeksLEAST_SQUARES_MEAN
SECONDARYSerum Triglycerides (TRG)96 weeks (slope of change mg/dl over 52 weeks)change in mg/dl/52 weeks over 96 weeksLEAST_SQUARES_MEAN
SECONDARYLDL Cholesterol96 weeks (expressed as a slope of change in mg/dl/52 weeks)change in mg/dl/52 weeks at 96 weeksLEAST_SQUARES_MEAN
SECONDARYHDL Cholesterol96 weeks (expressed as slope of change in mg/dL/52 weeks)change in mg/dl/52 weeks at 96 weeksLEAST_SQUARES_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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