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Insulin Tolerance Test Study in Patients With Type 1 Diabetes

NCT04026750 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-04-02

Study results available
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Summary

The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes

Conditions

Interventions

DRUG

Pitolisant

Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.

Sponsors & Collaborators

  • Ferox Therapeutics

    collaborator INDUSTRY

  • High Point Clinical Trials Center

    lead INDUSTRY

Principal Investigators

  • Melanie Fein, MD · PI

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2020-02-16
Completion
2020-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04026750 on ClinicalTrials.gov