Trial Outcomes & Findings for Lisofylline as Continuous Subcutaneous and Intravenous Administration in Subjects With Type 1 Diabetes Mellitus (NCT NCT01603121)

NCT ID: NCT01603121

Last Updated: 2016-08-18

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2016-08-18

Participant Flow

Participant milestones

Measure	Lisofylline Subcutaneous First, Then Lisofylline Intravenous Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period Lisofylline: 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.	Lisofylline Intravenous First, Then Lisofylline Subcutaneous Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period Lisofylline: 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.
First Intervention, 10 Hours STARTED	1	0
First Intervention, 10 Hours COMPLETED	1	0
First Intervention, 10 Hours NOT COMPLETED	0	0
Second Intervention, 10 Hours STARTED	1	0
Second Intervention, 10 Hours COMPLETED	0	0
Second Intervention, 10 Hours NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Lisofylline Subcutaneous First, Then Lisofylline Intravenous Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period Lisofylline: 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.	Lisofylline Intravenous First, Then Lisofylline Subcutaneous Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period Lisofylline: 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.
Second Intervention, 10 Hours Adverse Event	1	0

Baseline Characteristics

Lisofylline as Continuous Subcutaneous and Intravenous Administration in Subjects With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Measure	All Study Participants n=1 Participants Lisofylline: 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.
Age, Continuous	44 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

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).

Outcome measures

Outcome data not reported

Adverse Events

Lisofylline Subcutaneous

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Lisofylline Intravenous

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lisofylline Subcutaneous n=1 participants at risk Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period Lisofylline: 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.	Lisofylline Intravenous n=1 participants at risk Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period Lisofylline: 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.
General disorders Syncope	0.00% 0/1 Adverse events were assessed for through investigator assessment during the treatment period, and planned phone calls with patient following treatment periods.	100.0% 1/1 • Number of events 1 Adverse events were assessed for through investigator assessment during the treatment period, and planned phone calls with patient following treatment periods.
General disorders Hypotension	0.00% 0/1 Adverse events were assessed for through investigator assessment during the treatment period, and planned phone calls with patient following treatment periods.	100.0% 1/1 • Number of events 1 Adverse events were assessed for through investigator assessment during the treatment period, and planned phone calls with patient following treatment periods.

Other adverse events

Measure	Lisofylline Subcutaneous n=1 participants at risk Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period Lisofylline: 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.	Lisofylline Intravenous n=1 participants at risk Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period Lisofylline: 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.
General disorders Dizziness	100.0% 1/1 • Number of events 1 Adverse events were assessed for through investigator assessment during the treatment period, and planned phone calls with patient following treatment periods.	0.00% 0/1 Adverse events were assessed for through investigator assessment during the treatment period, and planned phone calls with patient following treatment periods.

Additional Information

Dr. David Lieb, Principal Investigator

Eastern Virginia Medical School

Phone: 7574465910

Email: liebdc@evms.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place