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

NCT04074317 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-03-27

Study results available
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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).

Conditions

  • Diabetes Mellitus, Type 1
  • Insulin-dependent Diabetes Mellitus

Interventions

DRUG

PRAM9

SC injection

DRUG

Regular Insulin + Pramlintide

Separate SC injections

DRUG

Regular Insulin

SC injection

Sponsors & Collaborators

  • Xeris Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Andrea Valasquez · Worldwide Clinical Trials

  • George Atiee · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2020-04-02
Completion
2020-04-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074317 on ClinicalTrials.gov