Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04026750
• Other study ID #: FPITO-T1D-01.01
• Status: Terminated
• Phase: Phase 1
• Start date: September 15, 2019
• Est. completion date: February 16, 2020

Study information

• Verified date: March 2021
• Source: High Point Clinical Trials Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 16, 2020
• Est. primary completion date: February 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	High Point Clinical Trials Center	High Point	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
High Point Clinical Trials Center	Ferox Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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