Trial · NCT04026750
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
NCT04026750, Phase 1, Terminated, High Point Clinical Trials Center; results first posted 2021-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Insulin Tolerance Test Study in Patients With Type 1 Diabetes. Trials, record NCT04026750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04026750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Insulin Tolerance Test Study in Patients With Type 1 Diabetes
- NCT number
- NCT04026750
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- High Point Clinical Trials Center
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Interventions
- Pitolisant
- First posted
- 2019-07-19
- Last updated
- 2021-04-02
- Results first posted
- 2021-04-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Peak Glucagon Response to Hypoglycemia | Change in peak glucagon during ITT Day 1 vs. Day 7 | pg/mL | MEAN | |
| SECONDARY | Number of Patients Returning to Blood Glucose =>70 mg/dL | Day 7 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Peak Glucagon Response to Hypoglycemia | Pitolisant 36mg | 7.5 | 95% Confidence Interval -2.07 to 17.02 | pg/mL | |
| Change From Baseline in Peak Glucagon Response to Hypoglycemia | Placebo | 13.1 | 95% Confidence Interval 2.08 to 24.07 | pg/mL | |
| Number of Patients Returning to Blood Glucose =>70 mg/dL | Pitolisant 36mg | 1 | Participants | ||
| Number of Patients Returning to Blood Glucose =>70 mg/dL | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pitolisant 36mg | 3 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | COMPLETED | Pitolisant 36mg | 3 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Pitolisant 36mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglycemia | Metabolism and nutrition disorders | Pitolisant 36mg | 3 | 3 | 55 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Placebo | 2 | 2 | 86 |
| other | Diarrhoea | Gastrointestinal disorders | Pitolisant 36mg | 1 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 2 | |
| other | Gastroenteritis viral | Infections and infestations | Pitolisant 36mg | 1 | 3 | |
| other | Gastroenteritis viral | Infections and infestations | Placebo | 0 | 2 | |
| other | Presyncope | Nervous system disorders | Pitolisant 36mg | 1 | 3 | |
| other | Presyncope | Nervous system disorders | Placebo | 0 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pitolisant 36mg | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, other adverse events | Pitolisant 36mg | 3 | 3 |
| Total, other adverse events | Placebo | 2 | 2 |
| Total, serious adverse events | Pitolisant 36mg | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pitolisant 36mg vs Placebo: Number of Patients Returning to Blood Glucose =>70 mg/dL | Trial comparisons |
| Pitolisant 36mg vs Placebo: deaths from any cause | Trial comparisons |
| Pitolisant 36mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04026750
GET https://conductscience.org/api/trials/v1/NCT04026750/registered