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A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
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Inclusion criteria
Patients must satisfy all of the following inclusion criteria to be included in 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.
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Data sourced from clinicaltrials.gov
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