Trial Outcomes & Findings for Insulin Tolerance Test Study in Patients With Type 1 Diabetes (NCT NCT04026750)
NCT ID: NCT04026750
Last Updated: 2021-04-02
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Change in peak glucagon during ITT Day 1 vs. Day 7
Results posted on
2021-04-02
Participant Flow
Participant milestones
| Measure |
Pitolisant 36mg
2-18mg tablets once daily for 7 days
|
Placebo
2- Placebo tablets to match pitolisant 18mg once daily for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Pitolisant 36mg
n=3 Participants
2-18 mg tablets per day for 7 days
|
Placebo
n=2 Participants
2-Placebo to match 18mg of pitolisant
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 5.57 • n=99 Participants
|
43.5 years
STANDARD_DEVIATION 12.02 • n=107 Participants
|
36.6 years
STANDARD_DEVIATION 9.56 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change in peak glucagon during ITT Day 1 vs. Day 7Change 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.
Outcome measures
| Measure |
Pitolisant 36mg
n=3 Participants
2-18mg tablets once daily for 7 days
|
Placebo
n=2 Participants
2- Placebo to match pitolisant 18mg once daily for 7 days
|
|---|---|---|
|
Change From Baseline in Peak Glucagon Response to Hypoglycemia
|
7.5 pg/mL
Interval -2.07 to 17.02
|
13.1 pg/mL
Interval 2.08 to 24.07
|
SECONDARY outcome
Timeframe: Day 7Number of patients that returned to blood glucose =\>70 mg/dL during ITT
Outcome measures
| Measure |
Pitolisant 36mg
n=3 Participants
2-18mg tablets once daily for 7 days
|
Placebo
n=2 Participants
2- Placebo to match pitolisant 18mg once daily for 7 days
|
|---|---|---|
|
Number of Patients Returning to Blood Glucose =>70 mg/dL
|
1 Participants
|
0 Participants
|
Adverse Events
Pitolisant 36mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pitolisant 36mg
n=3 participants at risk
2-18 mg tablets per day for 7 days
|
Placebo
n=2 participants at risk
2-Placebo to match 18mg of pitolisant
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
100.0%
3/3 • Number of events 55 • Day 1 to day 16
|
100.0%
2/2 • Number of events 86 • Day 1 to day 16
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Day 1 to day 16
|
0.00%
0/2 • Day 1 to day 16
|
|
Infections and infestations
Gastroenteritis viral
|
33.3%
1/3 • Day 1 to day 16
|
0.00%
0/2 • Day 1 to day 16
|
|
Nervous system disorders
Presyncope
|
33.3%
1/3 • Day 1 to day 16
|
0.00%
0/2 • Day 1 to day 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place