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Trial · NCT04074317

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYArea Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL0-180 minutes following administration of study drugThe number of participants analyzed were the number of participants with glucose \>180 mg/dL.min*mg/dLMEAN
SECONDARYMean Proportional Time for Plasma Glucose LevelsUp to 360 minutes following administration of study drug
The number of participants analyzed were the number of participants 0 to 90, 0 to 180, and 0 to 360 minutes after study drug administration with any evaluable plasma glucose concentration data. (While the number of participants noted for each datapoint had evaluable plasma glucose concentration data, not all of the participants had values in the range of plasma glucose concentration required for the analysis of the proportion of time with glucose concentrations in the specified range.)
percentage of timeMEAN
SECONDARYMean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dLDuring 40 to 180 minutes post-injection of study drug
The number of participants analyzed were the number of participants 0 to 90, 0 to 180, and 0 to 360 minutes after study drug administration with any evaluable plasma glucose concentration data. (While the number of participants noted for each data point had evaluable plasma glucose concentration data, not all of the participants had values in the range of plasma glucose concentration required for the analysis of the proportion of time with glucose concentrations in the specified range.)
percentage of timeMEAN
SECONDARYArea Under the Concentration (AUC) Curve for Plasma GlucoseUp to 360 minutes following administration of study drug
The number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements.~(The time period of 0 to 90 minutes after study drug administration with glucose \>250 mg/dL was not quantifiable.)
min*mg/dLMEAN
SECONDARYArea Over the Concentration (AOC) Curve for Plasma GlucoseUp to 360 minutes following administration of study drug
The number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements.~(There was no data available for the analysis of AOC0-90 for plasma glucose \<54 mg/dL.)
min*mg/dLMEAN
SECONDARYPlasma Glucose CmaxUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements.mg/dLMEAN
SECONDARYPlasma Glucose TmaxUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements.minutesMEAN
SECONDARYPramlintide CmaxUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide measurements.pg/mLMEAN
SECONDARYPramlintide TmaxUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide concentrations.minutesMEDIAN
SECONDARYPramlintide Area Under the Concentration (AUC) CurveUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide concentrations.min*pg/mLMEAN
SECONDARYInsulin CmaxUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable insulin measurements.pg/mLMEAN
SECONDARYInsulin TmaxUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable insulin concentrations.minutesMEDIAN
SECONDARYInsulin Area Under the Concentration (AUC) CurveUp to 360 minutes following administration of study drugThe number of participants analyzed were the number of participants after study drug administration with evaluable insulin concentrations.min*pg/mLMEAN

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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