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

NCT01603121 | Terminated Phase 1 Results DMC

• 1 other identifier: DL-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

lisofylline

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (2)

• Study Drug Bioavailability After Subcutaneous and Intravenous Infusion

  24 hours

• Evaluation of Early Efficacy of Study Drug

  24 hours

Study Arms (2)

Lisofylline subcutaneous

EXPERIMENTAL

Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period

Drug: Lisofylline

Lisofylline intravenous

EXPERIMENTAL

Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period

Drug: Lisofylline

Interventions

Lisofylline DRUG

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; Lisofylline subcutaneous

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Eastern Virginia Medical School Strelitz Diabetes Center

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

lisofylline

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Early termination due to difficulty recruiting subjects.

Results Point of Contact

• Title: Dr. David Lieb, Principal Investigator
• Organization: Eastern Virginia Medical School

liebdc@evms.edu

7574465910

Study Officials

• David C Lieb, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-08

Locations

US (1)