Trial · NCT04074317

Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D

NCT04074317, Phase 2, Completed, Xeris Pharmaceuticals; results first posted 2024-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D. Trials, record NCT04074317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04074317

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
NCT number: NCT04074317
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: Xeris Pharmaceuticals
Conditions: Diabetes Mellitus, Type 1, Insulin-dependent Diabetes Mellitus
Interventions: PRAM9, Regular Insulin + Pramlintide, Regular Insulin
First posted: 2019-08-30
Last updated: 2024-03-27
Results first posted: 2024-03-27

Source ClinicalTrials.gov

Registered outcomes13

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

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).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL	0-180 minutes following administration of study drug	The number of participants analyzed were the number of participants with glucose \>180 mg/dL.	min*mg/dL	MEAN
SECONDARY	Mean Proportional Time for Plasma Glucose Levels	Up 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 time	MEAN
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 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 time	MEAN
SECONDARY	Area Under the Concentration (AUC) Curve for Plasma Glucose	Up 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/dL	MEAN
SECONDARY	Area Over the Concentration (AOC) Curve for Plasma Glucose	Up 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/dL	MEAN
SECONDARY	Plasma Glucose Cmax	Up 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.	mg/dL	MEAN
SECONDARY	Plasma Glucose Tmax	Up 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.	minutes	MEAN
SECONDARY	Pramlintide Cmax	Up to 360 minutes following administration of study drug	The number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide measurements.	pg/mL	MEAN
SECONDARY	Pramlintide Tmax	Up to 360 minutes following administration of study drug	The number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide concentrations.	minutes	MEDIAN
SECONDARY	Pramlintide Area Under the Concentration (AUC) Curve	Up to 360 minutes following administration of study drug	The number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide concentrations.	min*pg/mL	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group103

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL	PRAM9		5019.6	Standard Deviation 4276.53	min*mg/dL
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL	Regular Insulin + Pramlintide		4591.9	Standard Deviation 3095.53	min*mg/dL
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL	Regular Insulin		13317.5	Standard Deviation 5262.42	min*mg/dL
Mean Proportional Time for Plasma Glucose Levels	PRAM9	>180 mg/dL: 0 to 90 minutes	5.6	Standard Deviation 13.61	percentage of time
Mean Proportional Time for Plasma Glucose Levels	Regular Insulin + Pramlintide	>180 mg/dL: 0 to 90 minutes	0.0	Standard Deviation 0.00	percentage of time
Mean Proportional Time for Plasma Glucose Levels	Regular Insulin	>180 mg/dL: 0 to 90 minutes	17.6	Standard Deviation 16.72	percentage of time
Mean Proportional Time for Plasma Glucose Levels	PRAM9	>180 mg/dL: 0 to 180 minutes	33.3	Standard Deviation 19.61	percentage of time
Mean Proportional Time for Plasma Glucose Levels	Regular Insulin + Pramlintide	>180 mg/dL: 0 to 180 minutes	31.3	Standard Deviation 13.44	percentage of time
Mean Proportional Time for Plasma Glucose Levels	Regular Insulin	>180 mg/dL: 0 to 180 minutes	58.7	Standard Deviation 14.57	percentage of time
Mean Proportional Time for Plasma Glucose Levels	PRAM9	>180 mg/dL: 0 to 360 minutes	45.8	Standard Deviation 24.79	percentage of time

1 to 10 of 103Source ClinicalTrials.gov

See all 103 results by group

Participant flow54

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Period	STARTED	PRAM9 to Regular Insulin to Regular Insulin+Pramlintide	3
First Period	STARTED	Regular Insulin to Regular Insulin+Pramlintide to PRAM9	3
First Period	STARTED	Regular Insulin+Pramlintide to PRAM9 to Regular Insulin	3
First Period	STARTED	PRAM9 to Regular Insulin+Pramlintide to Regular Insulin	3
First Period	STARTED	Regular Insulin to PRAM9 to Regular Insulin+Pramlintide	3
First Period	STARTED	Regular Insulin+Pramlintide to Regular Insulin to PRAM9	3
First Period	COMPLETED	PRAM9 to Regular Insulin to Regular Insulin+Pramlintide	3
First Period	COMPLETED	Regular Insulin to Regular Insulin+Pramlintide to PRAM9	3
First Period	COMPLETED	Regular Insulin+Pramlintide to PRAM9 to Regular Insulin	3
First Period	COMPLETED	PRAM9 to Regular Insulin+Pramlintide to Regular Insulin	3

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	PRAM9	2	18	2
other	Nausea	Gastrointestinal disorders	Regular Insulin + Pramlintide	1	18	1
other	Nausea	Gastrointestinal disorders	Regular Insulin	0	17	0
other	Asthenia	General disorders	PRAM9	1	18	1
other	Asthenia	General disorders	Regular Insulin + Pramlintide	0	18	0
other	Asthenia	General disorders	Regular Insulin	0	17	0
other	Injection site bruising	General disorders	PRAM9	0	18	0
other	Injection site bruising	General disorders	Regular Insulin + Pramlintide	1	18	1
other	Injection site bruising	General disorders	Regular Insulin	0	17	0
other	Injection site discomfort	General disorders	PRAM9	1	18	1

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PRAM9	0	18
Total, all-cause mortality	Regular Insulin + Pramlintide	0	18
Total, all-cause mortality	Regular Insulin	0	17
Total, other adverse events	PRAM9	10	18
Total, other adverse events	Regular Insulin + Pramlintide	9	18
Total, other adverse events	Regular Insulin	10	17
Total, serious adverse events	PRAM9	0	18
Total, serious adverse events	Regular Insulin + Pramlintide	0	18
Total, serious adverse events	Regular Insulin	0	17

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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