Registered outcomes13

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

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL	0-180 minutes following administration of study drug	The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL \* minutes) for plasma glucose \>180 mg/dL
Secondary	Mean Proportional Time for Plasma Glucose Levels	Up to 360 minutes following administration of study drug	The mean proportional times were evaluated for the following Plasma Glucose Levels: \>180 mg/dL, \>250 mg/dL, \<54 mg/dL, and \<70 The mean proportional times evaluated for each Plasma Glucose Level were during the following post-study drug injection periods: 0 to 90 minutes, 0 to 180 minutes, 0 to 360 minutes
Secondary	Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL	During 40 to 180 minutes post-injection of study drug	The mean proportional times to plasma glucose levels between 126 to 180 mg/dL following a glucose challenge administered 30 minutes post study drug administration.
Secondary	Area Under the Concentration (AUC) Curve for Plasma Glucose	Up to 360 minutes following administration of study drug	AUC0-t (mg/dL\*minutes) for plasma glucose X mg/dL, in which X = (\>180 mg/dL, \>250 mg/dL) and t = 90, 180, and 360 minutes
Secondary	Area Over the Concentration (AOC) Curve for Plasma Glucose	Up to 360 minutes following administration of study drug	AOC0-t (mg/dL\*minutes) for plasma glucose X mg/dL, in which X = \<54 mg/dL and \<70 mg/dL and t = 90, 180, and 360 minutes
Secondary	Plasma Glucose Cmax	Up to 360 minutes following administration of study drug	The maximum measured glucose concentrations over the time span.
Secondary	Plasma Glucose Tmax	Up to 360 minutes following administration of study drug	The time to maximum measured glucose concentrations.
Secondary	Pramlintide Cmax	Up to 360 minutes following administration of study drug	The maximum measured pramlintide concentrations (arithmetic mean).
Secondary	Pramlintide Tmax	Up to 360 minutes following administration of study drug	The time to maximum measured pramlintide concentrations.
Secondary	Pramlintide Area Under the Concentration (AUC) Curve	Up to 360 minutes following administration of study drug	The pramlintide area under the concentration time curve after study drug administration (arithmetic mean).
Secondary	Insulin Cmax	Up to 360 minutes following administration of study drug	The maximum measured insulin concentrations (arithmetic mean)
Secondary	Insulin Tmax	Up to 360 minutes following administration of study drug	The time to maximum measured insulin concentrations.
Secondary	Insulin Area Under the Concentration (AUC) Curve	Up to 360 minutes following administration of study drug	The insulin area under the concentration time curve after study drug administration.

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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