Insulin Tolerance Test Study in Patients With Type 1 Diabetes

High Point Clinical Trials Center

Status and phase: Terminated; Phase 1

Conditions: Hypoglycemia; Type 1 Diabetes

Treatments: Drug: Pitolisant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04026750

FPITO-T1D-01.01

Details and patient eligibility

About

The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Pitolisant

Experimental group

Treatment:

Drug: Pitolisant

Matching placebo

Placebo Comparator group

Treatment:

Drug: Pitolisant