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Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pitolisant
Sponsored by
High Point Clinical Trials Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria: Diagnosis of diabetes => 4yrs, On Insulin => 4yrs, HbA1c<= 10%, At least one episode of severe hypoglycemia in past 12 months, fasting c-peptide <0.7 ng/ml

Exclusion Criteria:

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

Sites / Locations

  • High Point Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pitolisant

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients Returning to Blood Glucose =>70 mg/dL
Number of patients that returned to blood glucose =>70 mg/dL during ITT

Full Information

First Posted
July 17, 2019
Last Updated
March 9, 2021
Sponsor
High Point Clinical Trials Center
Collaborators
Ferox Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04026750
Brief Title
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Official Title
A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Based on scientific data collected during the trial and high screen fail rate.
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
February 16, 2020 (Actual)
Study Completion Date
February 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
High Point Clinical Trials Center
Collaborators
Ferox Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitolisant
Arm Type
Experimental
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pitolisant
Intervention Description
Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
Primary Outcome Measure Information:
Title
Change From Baseline in Peak Glucagon Response to Hypoglycemia
Description
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.
Time Frame
Change in peak glucagon during ITT Day 1 vs. Day 7
Secondary Outcome Measure Information:
Title
Number of Patients Returning to Blood Glucose =>70 mg/dL
Description
Number of patients that returned to blood glucose =>70 mg/dL during ITT
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria: Diagnosis of diabetes => 4yrs, On Insulin => 4yrs, HbA1c<= 10%, At least one episode of severe hypoglycemia in past 12 months, fasting c-peptide <0.7 ng/ml Exclusion Criteria: Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Fein, MD
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
High Point Clinical Trials Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Insulin Tolerance Test Study in Patients With Type 1 Diabetes

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