Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Type 1 Diabetes, Hypoglycemia

In brief

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

Key facts

Study ID

NCT04026750

Run by

High Point Clinical Trials Center

People needed

5

Starts

2019-09-15

Expected to finish

2020-02-16

Last updated by the study team

2021-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression

Where it is running

• High Point Clinical Trials Center — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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