A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus

Inclusion criteria

Patients must satisfy all of the following inclusion criteria to be included in the study:

• be male or female between the ages of18 and 65 years, inclusive;
• have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
• have a current physical examination that reveals no clinically significant abnormalities;
• have no clinically significant abnormalities in vital signs;
• have a body mass index (BMI) <38;
• have a glycosylated hemoglobin (HbA1c) > 8 and <12;
• have a C-peptide level >3 ng/mL;
• have a typical fasting blood glucose levels of < 200 mg/dl (+/- 25 mg/dl);
• be available for the entire study period, and be able and willing to adhere to protocol requirements;
• if female of childbearing potential, must be using a reliable form of birth control; and,
• provide written informed consent prior to admission into the study.

Exclusion criteria

• have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin;
• have a history of drug or alcohol dependency or psychological disease;
• have any clinically significant illness during the 4 weeks prior to admission into the study;
• require regular use of medication that interferes with the absorption and/or metabolism of insulin;
• recent use (within 48 hours) of medications that interfere with blood glucose analyses, i.e., mannose, acetaminophen, dopamine, and ascorbic acid, which are all reported to alter glucose-oxidase type blood glucose analytical methods;
• use of Avandia or Actos for treating diabetes;
• participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
• use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
• are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year;

• have a history of ketoacidosis;

• have any acute illness within 2 weeks prior to Screening; or,

• have elevated liver enzymes (ALT, AST, alkaline phosphatase) >1.5 times the upper limit of normal.