Status:
TERMINATED
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Lead Sponsor:
High Point Clinical Trials Center
Collaborating Sponsors:
Ferox Therapeutics
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
Eligibility Criteria
Inclusion
- 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
- Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04026750
Start Date
September 15 2019
End Date
February 16 2020
Last Update
April 2 2021
Active Locations (1)
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1
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265