Insulin Tolerance Test Study in Patients With Type 1 Diabetes

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

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

Study Overview

• Status: Terminated
• Conditions: Hypoglycemia; Type 1 Diabetes
• Intervention / Treatment: Drug: Pitolisant

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27265
      • High Point Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Matching placebo	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.
EXPERIMENTAL: Pitolisant	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Returning to Blood Glucose =>70 mg/dL	Number of patients that returned to blood glucose =>70 mg/dL during ITT	Day 7

Collaborators and Investigators

• Sponsor: High Point Clinical Trials Center
• Collaborators: Ferox Therapeutics
• Investigators: Principal Investigator: Melanie Fein, MD, PI

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2019
• Primary Completion (ACTUAL): February 16, 2020
• Study Completion (ACTUAL): February 16, 2020

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: FPITO-T1D-01.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No