Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 Diabetes
Public ClinicalTrials.gov record NCT00896077. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Safety, Tolerability and Bioavailability Study of Lisofylline After Continuous Subcutaneous (12 mg/kg) and Intravenous (12 mg/kg) Administration in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Autoimmune diseases happen when the immune system does not identify part of the body as belonging to it. The immune system then destroys that part as if it were an unknown tissue in the body. In T1DM, the body kills the cells in the pancreas that produce insulin. Insulin is the hormone that "unlocks" the cells of the body. It allows glucose to enter and fuel them. Special cells in the body called islets make the insulin. Since glucose cannot enter the cells, it builds up in the blood. The body's cells literally starve to death. Children are at risk of developing T1DM and the risk is much higher than other severe, chronic childhood diseases. The only treatments are a careful diet, planned physical activity, and testing blood sugar levels several times a day. The patient must also inject insulin each day or use an insulin pump. There is no cure for T1DM. Insulin injections are considered life support, because going without insulin for just a few days causes the blood to have too much acid in it and that can lead to death. On the other hand, taking too much insulin makes blood sugar levels go too low, and if untreated, can lead to death as well. DiaKine is developing Lisofylline to treat the failed immune system. This is what caused T1DM in the first place and it does not go away. The purpose of this study is to see how safe the study drug is. The study is also going to compare the levels of study drug in the blood and to measure the effect of the study drug on other substances in the blood that are linked to type 1 diabetes. These levels will be measured after the study drug is given as an injection under the skin and an injection into the vein. To date, Lisofylline has been tested when given as an injection in the vein. The investigators hypothesize that Lisofylline will be safe when given as an injection under the skin and in the vein and that levels of study drug will be very similar when given as an injection under the skin and in the vein. The investigators also hypothesize that Lisofylline will have a positive effect on the substances in the blood that are linked to type 1 diabetes.
Study identification
- NCT ID
- NCT00896077
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2009
- Primary completion
- Nov 30, 2009
- Completion
- Nov 30, 2009
- Last update posted
- Jul 28, 2014
2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Biomedical Research, Inc. (ABR) | Hackensack | New Jersey | 07601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00896077, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2014 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00896077 live on ClinicalTrials.gov.