Type 1 DiabetesEarly Phase 1NCT00780650
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
A Early Phase 1 study testing Atomoxetine in people with Type 1 Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 21 Aug 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Atomoxetine, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called Strattera
80 mg oral dose, once per day for 6 weeks
PlaceboDrug
80 mg dose once per day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Atomoxetine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of catecholamines in blood from baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startMay 2009
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Stephen N. Davis, MBBS, University of Maryland, Baltimore
- Investigators
- Stephen N. Davis, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780650
- Sponsor's protocol ID
- HP-00044873
- Status last verified
- Sep 2019
- First submitted
- 24 Oct 2008
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
- ClinicalTrials.gov ID
- NCT00780650
- Acronym / sponsor ID
- HP-00044873
- Conditions
- Type 1 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2009
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Atomoxetine |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtomoxetineAlso: Strattera80 mg oral dose, once per day for 6 weeks | Drug | 1 |
| Placebo80 mg dose once per day for 6 weeks | Drug | 2 |
Primary outcome
Change in level of catecholamines in blood from baseline
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N. Davis, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Atomoxetine in people with Type 1 Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of catecholamines in blood from baseline (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.