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Clinical Trial Details

Trial ID: L4492
Source ID: NCT04074317
Associated Drug: Pram9
Title: Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04074317/results
Conditions: Diabetes Mellitus, Type 1|Insulin-dependent Diabetes Mellitus
Interventions: DRUG: PRAM9|DRUG: Regular Insulin + Pramlintide|DRUG: Regular Insulin
Outcome Measures: Primary: Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL, 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, 0-180 minutes following administration of study drug | Secondary: Mean Proportional Time for Plasma Glucose Levels, 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, Up to 360 minutes following administration of study drug|Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL, 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., During 40 to 180 minutes post-injection of study drug|Area Under the Concentration (AUC) Curve for Plasma Glucose, 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, Up to 360 minutes following administration of study drug|Area Over the Concentration (AOC) Curve for Plasma Glucose, 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, Up to 360 minutes following administration of study drug|Plasma Glucose Cmax, The maximum measured glucose concentrations over the time span., Up to 360 minutes following administration of study drug|Plasma Glucose Tmax, The time to maximum measured glucose concentrations., Up to 360 minutes following administration of study drug|Pramlintide Cmax, The maximum measured pramlintide concentrations (arithmetic mean)., Up to 360 minutes following administration of study drug|Pramlintide Tmax, The time to maximum measured pramlintide concentrations., Up to 360 minutes following administration of study drug|Pramlintide Area Under the Concentration (AUC) Curve, The pramlintide area under the concentration time curve after study drug administration (arithmetic mean)., Up to 360 minutes following administration of study drug|Insulin Cmax, The maximum measured insulin concentrations (arithmetic mean), Up to 360 minutes following administration of study drug|Insulin Tmax, The time to maximum measured insulin concentrations., Up to 360 minutes following administration of study drug|Insulin Area Under the Concentration (AUC) Curve, The insulin area under the concentration time curve after study drug administration., Up to 360 minutes following administration of study drug
Sponsor/Collaborators: Sponsor: Xeris Pharmaceuticals
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-08-22
Completion Date: 2020-04-02
Results First Posted: 2024-03-27
Last Update Posted: 2024-03-27
Locations: World Wide Clinical Trials, San Antonio, Texas, 78217, United States
URL: https://clinicaltrials.gov/show/NCT04074317