Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02897557 - Insulet Artificial Pancreas Early Feasibility Study N/A
Completed NCT02855307 - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes Phase 2