Clinical trial NCT01603121 (phase 1/phase 2, status: terminated)
Conditions: type 1 diabetes mellitus
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: lisofylline
SMILES: C[C@@H](O)CCCCN1C(=O)N(C)C2=C(N(C)C=N2)C1=O
Reason stopped: 
    unable to enroll sufficient number of subjects
  
Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  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

        Exclusion Criteria:

          -  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

          -  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