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NCT04074317 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, sponsored by Xeris Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
18
Enrollment target
1
Study location

NCT04074317 is a Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 18 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04074317, a Phase 2 study of Diabetes Mellitus, Type 1 and Insulin-dependent Diabetes Mellitus, has completed, sponsored by Xeris Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).

Interventions

  • DRUG Regular Insulin
  • DRUG PRAM9
  • DRUG Regular Insulin + Pramlintide

Study Locations (1)

Texas

  • World Wide Clinical Trials - San Antonio

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2019-08-22
Est. Completion 2020-04-02
Phase Phase 2

Sponsor

Xeris Pharmaceuticals

14 total trials

What the Registry Record Tells You About NCT04074317

The ClinicalTrials.gov registry entry for NCT04074317 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (99% lower). The listed sponsor is Xeris Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Regular Insulin is the first listed.

NCT04074317 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04074317 about?

NCT04074317 is a clinical study titled "Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D". This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).

What is the current status of trial NCT04074317?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-08-22. Estimated completion is 2020-04-02.

What conditions does trial NCT04074317 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Insulin-dependent Diabetes Mellitus.

What interventions are being tested in trial NCT04074317?

The interventions under investigation include: Regular Insulin (DRUG), PRAM9 (DRUG), Regular Insulin + Pramlintide (DRUG).

Who is sponsoring clinical trial NCT04074317?

This trial is sponsored by Xeris Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04074317 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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