NCT04026750

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

July 17, 2019

Results QC Date

February 11, 2021

Last Update Submit

March 9, 2021

Conditions

Type 1 DiabetesHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Peak Glucagon Response to Hypoglycemia

    Change in peak glucagon concentration from day 1 ITT (baseline) to day 7 ITT (on treatment). Serial glucagon collected during ITT's, occurred at -10, 0, 15, 30, 45, 60, 90, 120 and 180 minutes just prior to and during the ITT.

    Change in peak glucagon during ITT Day 1 vs. Day 7

Secondary Outcomes (1)

  • Number of Patients Returning to Blood Glucose =>70 mg/dL

    Day 7

Study Arms (2)

Pitolisant

EXPERIMENTAL
Drug: Pitolisant

Matching placebo

PLACEBO COMPARATOR
Drug: Pitolisant

Interventions

PitolisantDRUG

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

Matching placeboPitolisant

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

pitolisant

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Melanie Fein, MD
Organization
High Point Clinical Trials Center
mfein@highpointctc.com
1-336-841-0700

Study Officials

  • Melanie Fein, MD

    PI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 19, 2019

Study Start

September 15, 2019

Primary Completion

February 16, 2020

Study Completion

February 16, 2020

Last Updated

April 2, 2021

Results First Posted

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)