Insulin Tolerance Test Study in Patients With Type 1 Diabetes

• Status: Terminated
• Trial end date: 2020-02-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clayton A. Dehn; High Point Clinical Trials Center
• Collaborator: Ferox Therapeutics

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