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Insulin Tolerance Test Study to Assess Safety, Tolerability and Pharmacodynamics of Pitolisant in Patients With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT04026750
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Ferox Therapeutics
Information provided by (Responsible Party):
Clayton A. Dehn, 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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Hypoglycemia Drug: Pitolisant Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Pitolisant Drug: Pitolisant
Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.

Placebo Comparator: Matching placebo Drug: Pitolisant
Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.




Primary Outcome Measures :
  1. Peak glucagon concentration [ Time Frame: Day 7 ]
    Change from baseline in peak glucagon concentration during ITT

  2. Incidence and severity of TEAEs [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Glucose area under the curve [ Time Frame: Day 7 ]
    Change in glucose area under the curve during ITT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026750


Locations
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United States, North Carolina
High Point Clinical Trials Center Recruiting
High Point, North Carolina, United States, 27265
Contact: Clayton A. Dehn, M.S.    336-841-0700 ext 2522    cdehn@highpointctc.com   
Principal Investigator: Clayton A. Dehn, M.S.         
Sponsors and Collaborators
Clayton A. Dehn
Ferox Therapeutics

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Responsible Party: Clayton A. Dehn, Vice President, Clinical Pharmacology Services, High Point Clinical Trials Center
ClinicalTrials.gov Identifier: NCT04026750     History of Changes
Other Study ID Numbers: FPITO-T1D-01.01
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs