Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself against low blood sugar.

Key facts

Study ID

NCT00780650

Run by

University of Maryland, Baltimore

People needed

56

Starts

2009-05-01

Expected to finish

2018-08-21

Last updated by the study team

2019-09-12

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy individuals aged 18-50 years
• Type 1 Diabetes individuals aged 18-50 years
• BMI <40 kg/m2
• Females of childbearing potential with negative urine pregnancy test
• Volunteers over 40 years of age, a cardiac stress test with no clinically significant conduction or ischemic changes

You may not qualify if…

• The following groups of subjects will be excluded from the study:
• Pregnant women
• Subjects unable to give voluntary informed consent
• Subjects on anticoagulant drugs or with known bleeding diatheses
• Subjects with uncontrolled hypertension, heart disease, cerebrovascular incidents
• Subjects taking MAOIs
• Subjects with narrow angle glaucoma
• Subjects with diagnosed psychiatric disorders
• Subjects with allergy to atomoxetine, heparin, or lidocaine
• Physical Exam Exclusion Criteria:
• Uncontrolled severe hypertension (i.e., blood pressure greater than 150/95)
• Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects > 40 years old.
• Pneumonia
• Hepatic Failure/Jaundice
• Renal Failure
• Acute Cerebrovascular/ Neurological deficit
• Fever greater than 38.0 C
• Screening Laboratory Tests Exclusion Criteria Blood values as defined in protocol

Where it is running

• Univerisity of Maryland, Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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