Hypoglycemia, Type 1 Diabetes
Conditions
Brief summary
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
Interventions
DRUGPitolisant
Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
Sponsors
Ferox Therapeutics
High Point Clinical Trials Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pitolisant 36mg 2-18 mg tablets per day for 7 days | 3 |
| Placebo 2-Placebo to match 18mg of pitolisant | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Placebo | Total | Pitolisant 36mg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 3 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 12.02 | 36.6 years STANDARD_DEVIATION 9.56 | 32 years STANDARD_DEVIATION 5.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 5 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
Change From Baseline in Peak Glucagon Response to Hypoglycemia
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.
Time frame: Change in peak glucagon during ITT Day 1 vs. Day 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pitolisant 36mg | Change From Baseline in Peak Glucagon Response to Hypoglycemia | 7.5 pg/mL |
| Placebo | Change From Baseline in Peak Glucagon Response to Hypoglycemia | 13.1 pg/mL |
Secondary
Number of Patients Returning to Blood Glucose =>70 mg/dL
Number of patients that returned to blood glucose =\>70 mg/dL during ITT
Time frame: Day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pitolisant 36mg | Number of Patients Returning to Blood Glucose =>70 mg/dL | 1 Participants |
| Placebo | Number of Patients Returning to Blood Glucose =>70 mg/dL | 0 Participants |