Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00780650

Enrollment

Registered

2008-10-27

Start date

2009-05-31

Completion date

2018-08-21

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

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.

Detailed description

The purpose of this study is to see if the drug atomoxetine (Strattera) has effects on the body's ability to defend itself against low blood sugar. Normally, when blood sugar levels drop below normal, the body creates a series of responses, which increase the sugar inside the body to bring blood sugar levels back to normal. The hormone epinephrine is a key defense against low blood sugar in people with diabetes. Atomoxetine has been shown to increase this hormone level. Thus, any approaches to increase levels of this key defense during low blood sugar may have great value.

Interventions

DRUGAtomoxetine

80 mg oral dose, once per day for 6 weeks

DRUGPlacebo

80 mg dose once per day for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in level of catecholamines in blood from baseline	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026