Restoration of Hypoglycemia Awareness With Metoclopramide

ConditionHypoglycemia Unawareness

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age20-60

SponsorSimon Fisher

About this trial

Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.

Eligibility criteria

Qualifiers

Subjects with Type 1 Diabetes Mellitus

Diabetes duration > 5 years

Hemoglobin A1c ≤ 9%

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Disqualifiers

History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency

History of stroke or brain disease

History of genitourinary obstruction or urinary retention

Advanced liver disease

Trial design

Treatments tested in this trial

Metoclopramide
Placebo

Treatment groups

36 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Simon Fisher

Lead sponsor

University of Kentucky

Sponsor institution

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov