Conditions: Type 1 Diabetes Mellitus
Keywords: lisofylline
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 1
Healthy volunteers: no

Brief 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. 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.

Arms:
arm 1: Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period arm 2: Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period

Interventions: intervention 1: Lisofylline
Intervention descriptions: intervention 1: 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.

Protocol document: