Insulin Tolerance Test Study in Patients With Type 1 Diabetes
- Registration Number
- NCT04026750
- Lead Sponsor
- High Point Clinical Trials Center
- Brief Summary
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching placebo Pitolisant - Pitolisant Pitolisant -
- Primary Outcome Measures
Name Time Method Change From Baseline in Peak Glucagon Response to Hypoglycemia 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.
- Secondary Outcome Measures
Name Time Method Number of Patients Returning to Blood Glucose =>70 mg/dL Day 7 Number of patients that returned to blood glucose =\>70 mg/dL during ITT
Trial Locations
- Locations (1)
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States