Type 1 DiabetesPhase 1NCT04026750
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
A Phase 1 study testing Pitolisant in people with Type 1 Diabetes and Hypoglycemia, run by High Point Clinical Trials Center at 1 site in United States.
Trial summary
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Pitolisant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2019to 16 Feb 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point Clinical Trials Center
High Point, North Carolina, 27265
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Pitolisant
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitolisantDrug
Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant | Experimental | Not described Receives: Drug: Pitolisant |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Pitolisant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in peak glucagon during ITT Day 1 vs. Day 7
Secondary outcomes (1)
Number of Patients Returning to Blood Glucose =>70 mg/dL
Number of patients that returned to blood glucose =>70 mg/dL during ITT
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start15 Sep 2019
- Primary completion16 Feb 2020
- Study completion16 Feb 2020
Why it stopped: Based on scientific data collected during the trial and high screen fail rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point Clinical Trials Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferox Therapeutics
- Responsible party
- Sponsor
- Investigators
- Melanie Fein, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026750
- Sponsor's protocol ID
- FPITO-T1D-01.01
- Status last verified
- Mar 2021
- First submitted
- 17 Jul 2019
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04026750
- Acronym / sponsor ID
- FPITO-T1D-01.01
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on scientific data collected during the trial and high screen fail rate.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- High Point Clinical Trials CenterIndustry (pharma, biotech, devices)
- Collaborators
- Ferox Therapeutics
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 16 Feb 2020 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 2 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitolisant | Experimental | Drug: Pitolisant |
| Matching placebo | Placebo comparator | Drug: Pitolisant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitolisantPitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated. | Drug | Matching placebo, Pitolisant |
Primary outcome
Change From Baseline in Peak Glucagon Response to Hypoglycemia
Time frame: 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.
1 secondary outcome
Number of Patients Returning to Blood Glucose =>70 mg/dL
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Fein, MD principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pitolisant in people with Type 1 Diabetes and Hypoglycemia, run by High Point Clinical Trials Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peak Glucagon Response to Hypoglycemia (time frame: Change in peak glucagon during ITT Day 1 vs. Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.