Type 1 Diabetes MellitusPhase 1/2NCT01603121
Lisofylline as Continuous Subcutaneous and Intravenous Administration in Subjects With Type 1 Diabetes Mellitus
A Phase 1/2 study testing Lisofylline in people with Type 1 Diabetes Mellitus, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
The primary goal of the study is to investigate the safety and tolerability of the investigational drug lisofylline, when administered under the skin or in the vein, in people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Lisofylline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adults between the ages of 18 and 45 years of age
- Ability to understand and provide written informed consent
- Ability to complete the study in compliance with the protocol
- If female, subjects must be non-pregnant and non-lactating, and willing to use appropriate and adequate contraception during the study
- If male, subjects must be willing to use effective birth control during the study
- Weight at least 50 kgs (110 lbs)
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- Body mass index between 18.5 and 30 kg/m2
- QTc < 450 msec at screening
- Clinical diagnosis of type 1 diabetes at least 2 years prior to screening
- Treatment with insulin for at least 1 year and on a stable dose for at least 3 months prior to screening (dose must be < 0.8 units/kg/day)
- Subjects must self-monitor blood glucose levels at least daily
- HbA1c 6-9%
- Serum c-peptide level < 0.6 ng/mL
- Serum creatinine < 1.5 mg/dL for males and < 1.4 mg/dL for females
- Negative hepatitis B, hepatitis C and HIV testing at screening or within 3 months of screening
- Subjects must be free from clinically significant abnormal findings at the time of screening (to include abnormalities on examination, medical history, electrocardiogram, clinical laboratory testing); to be determined by principal investigator
Who cannot join
- Subjects with significant stomach, liver, kidney or heart disease, including high blood pressure, stroke or other blood vessel disease. Significant eye problems due to diabetes, diabetic nerve disease, or non-healed diabetic foot ulcers
- Personal or family history of long QTc syndrome
- History of clinically significant changes in orthostatic blood pressure
- Clinically significant changes in orthostatic blood pressure at screening
- History of peptic ulcer disease and/or gastrointestinal bleeding/perforation
- History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease
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- History of severe peripheral or autonomic neuropathy in the opinion of the study physician
- History of hypoglycemia unawareness, and/or episodes of severe hypoglycemia within 60 days of screening
- Diagnosis of type 2 diabetes, based upon subject report
- Use of oral antihyperglycemic medications, pentoxyifylline, and/or theophylline
- Use of any drug therapy that directly affects gastrointestinal motility
- History of any significant drug allergy
- History of difficulty with phlebotomy
- Use of any recreational drugs within the past year or a previous history of drug or alcohol abuse
- Positive results from a screen for alcohol or substances of abuse at screening or upon admission to the study site
- Current smoker or user of any tobacco products
- Use of prescription medications is acceptable at the Principal Investigator's discretion if they have been part of a stable drug regimen documented for the last 60 days. Drug therapy should be held the morning of Day 1 and Day 7 at the Principal Investigator's discretion
- use of any over-the-counter drugs or herbal preparations within 72 hours prior to receiving study drug
- Consumption of any caffeine-containing foods or beverages within 24 hours prior to receiving study drug
- Consumption of alcohol within 24 hours prior to admission to the study site
- Consumption of any grapefruit or grapefruit-containing juices within 72 hours prior to receiving study drug
- Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving drug
- Prior exposure to lisofylline
- Donation of blood (1 pint or more) within 30 days or plasma within 7 days of receiving study drug
- Any condition which in the opinion of the study investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he or she took part in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School Strelitz Diabetes Center
Norfolk, Virginia, 23510
About this study
Official title: A Safety, Tolerability and Bioavailability Study of Lisofylline After Continuous Subcutaneous (12 mg/kg) and Intravenous (9 mg/kg) Administration in Subjects With Type 1 Diabetes Mellitus
The primary goal of the study is to investigate the safety and tolerability of the investigational drug lisofylline, when administered under the skin or in the vein, in people with type 1 diabetes. A second aim is to determine how much drug is available in the blood after injection under the skin, compared to injection in the vein.
Read the detailed description
This is an open-label, randomized, crossover study in subjects with type 1 diabetes. There are two treatment periods separated by approximately one week. One treatment will consist of a 10 hour subcutaneous infusion of lisofylline, and the other treatment will consist of a 10 hour intravenous infusion of lisofylline.
Eligible subjects will be admitted to the Infusion Center the morning of dosing (Day 1, Day 7) during each treatment period, receive their assigned dose of study drug on Day 1 and Day 7, and will remain confined to the Infusion Center until approximately 3 hours following the start of study drug administration for the remaining blood draws. The subjects will then be escorted to the Sleep Center of Eastern Virginia Medical School for an overnight stay during which time their heart rate and oxygen saturation will be monitored by pulse oximetry. The next morning the subjects will return to the Infusion Center for a final blood draw and physical examination. The Infusion Center and the Sleep Disorders Center are both within Sentara Norfolk General Hospital.
All subjects will be assigned to a treatment sequence according to a randomization schedule.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Lisofylline
- Keywords
- lisofylline
- 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.
LisofyllineDrug
Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
| Study group | Role | What they receive |
|---|---|---|
| Lisofylline subcutaneous | Experimental | Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period Receives: Drug: Lisofylline |
| Lisofylline intravenous | Experimental | Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period Receives: Drug: Lisofylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Study Drug
Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests.
Study staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly.
Measured: 1 month
Secondary outcomes (2)
Study Drug Bioavailability After Subcutaneous and Intravenous Infusion
Blood will be collected for determination of lisofylline concentrations at various predetermined time points during the infusions, and 10 and 24 hours following infusion completion. This will help to determine if subcutaneous infusion over 10 hours results in similar lisofylline plasma concentrations as with intravenous infusion.
Measured: 24 hours
Evaluation of Early Efficacy of Study Drug
Blood draws will be performed at predetermined time points during and after the infusions in order to measure serum cytokine and chemokine concentrations, as well as to measure plasma STAT 4 and phosphorylated STAT 4 (markers of lisofylline efficacy).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Unable to enroll sufficient number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Lieb, MD, Eastern Virginia Medical School
- Investigators
- David C Lieb, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603121
- Sponsor's protocol ID
- DL-001
- Status last verified
- Aug 2016
- First submitted
- 18 May 2012
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability and Bioavailability Study of Lisofylline After Continuous Subcutaneous (12 mg/kg) and Intravenous (9 mg/kg) Administration in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01603121
- Acronym / sponsor ID
- DL-001
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- lisofylline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll sufficient number of subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Posted 18 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the study is to investigate the safety and tolerability of the investigational drug lisofylline, when administered under the skin or in the vein, in people with type 1 diabetes. A second aim is to determine how much drug is available in the blood after injection under the skin, compared to injection in the vein.
Detailed description
This is an open-label, randomized, crossover study in subjects with type 1 diabetes. There are two treatment periods separated by approximately one week. One treatment will consist of a 10 hour subcutaneous infusion of lisofylline, and the other treatment will consist of a 10 hour intravenous infusion of lisofylline.
Eligible subjects will be admitted to the Infusion Center the morning of dosing (Day 1, Day 7) during each treatment period, receive their assigned dose of study drug on Day 1 and Day 7, and will remain confined to the Infusion Center until approximately 3 hours following the start of study drug administration for the remaining blood draws. The subjects will then be escorted to the Sleep Center of Eastern Virginia Medical School for an overnight stay during which time their heart rate and oxygen saturation will be monitored by pulse oximetry. The next morning the subjects will return to the Infusion Center for a final blood draw and physical examination. The Infusion Center and the Sleep Disorders Center are both within Sentara Norfolk General Hospital.
All subjects will be assigned to a treatment sequence according to a randomization schedule.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisofylline subcutaneous | Experimental | Drug: LisofyllineLisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period |
| Lisofylline intravenous | Experimental | Drug: LisofyllineLisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male or female adults between the ages of 18 and 45 years of age
- Ability to understand and provide written informed consent
- Ability to complete the study in compliance with the protocol
- If female, subjects must be non-pregnant and non-lactating, and willing to use appropriate and adequate contraception during the study
- If male, subjects must be willing to use effective birth control during the study
Key exclusion criteria (25 listed)
- Subjects with significant stomach, liver, kidney or heart disease, including high blood pressure, stroke or other blood vessel disease. Significant eye problems due to diabetes, diabetic nerve disease, or non-healed diabetic foot ulcers
- Personal or family history of long QTc syndrome
- History of clinically significant changes in orthostatic blood pressure
- Clinically significant changes in orthostatic blood pressure at screening
- History of peptic ulcer disease and/or gastrointestinal bleeding/perforation
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 |
|---|---|---|
| LisofyllineLisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart. | Drug | Lisofylline intravenous, Lisofylline subcutaneous |
Primary outcome
Safety and Tolerability of Study Drug
Time frame: 1 month
Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests. Study staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly.
2 secondary outcomes
Study Drug Bioavailability After Subcutaneous and Intravenous Infusion
Time frame: 24 hours
Evaluation of Early Efficacy of Study Drug
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David C Lieb, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lisofylline in people with Type 1 Diabetes Mellitus, run by Eastern Virginia Medical School 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 16 inclusion and 25 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: stopped early, as of the sponsor's last update on 18 Aug 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability of Study Drug (time frame: 1 month). 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 18 Aug 2016.