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

High Point Clinical Trials Center1 site in 1 country5 target enrollmentSeptember 15, 2019

ConditionsType 1 Diabetes Hypoglycemia

InterventionsPitolisant

DrugsPitolisant

Overview

Phase: Phase 1
Intervention: Pitolisant
Conditions: Type 1 Diabetes
Sponsor: High Point Clinical Trials Center
Enrollment: 5
Locations: 1
Primary Endpoint: Change From Baseline in Peak Glucagon Response to Hypoglycemia
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 15, 2019

End Date

February 16, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

High Point Clinical Trials Center

Responsible Party

Sponsor

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

Arms & Interventions

Matching placebo

Intervention: Pitolisant

Pitolisant

Intervention: Pitolisant

Outcomes

Primary Outcomes

Change From Baseline in Peak Glucagon Response to Hypoglycemia

Time Frame: Change in peak glucagon during ITT Day 1 vs. Day 7

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.