Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Phase 1TerminatedNCT04026750

High Point Clinical Trials Center5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes Hypoglycemia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

High Point Clinical Trials Center

High Point, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Change in peak glucagon during ITT Day 1 vs. Day 7

Secondary Outcomes

Number of Patients Returning to Blood Glucose =>70 mg/dL

Number of patients that returned to blood glucose =\>70 mg/dL during ITT

Time frame: Day 7

Data from ClinicalTrials.gov

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