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NCT04026750 Clinical Trial

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
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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