Title
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
Phase
Phase 1Lead Sponsor
High Point Clinical Trial CenterStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Type 1 Diabetes HypoglycemiaIntervention/Treatment
PitolisantStudy Participants
5The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
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
| Event Type | Organ System | Event Term | Pitolisant 36mg | Placebo |
|---|
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.
Number of patients that returned to blood glucose =>70 mg/dL during ITT
