Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Diasome Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. be male or female between the ages of18 and 65 years, inclusive;
2. have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
3. have a current physical examination that reveals no clinically significant abnormalities;
4. have no clinically significant abnormalities in vital signs;
5. have a body mass index (BMI) \<38;
6. have a glycosylated hemoglobin (HbA1c) \> 8 and \<12;
7. have a C-peptide level \>3 ng/mL;
8. have a typical fasting blood glucose levels of \< 200 mg/dl (+/- 25 mg/dl);
9. be available for the entire study period, and be able and willing to adhere to protocol requirements;
10. if female of childbearing potential, must be using a reliable form of birth control; and,
11. provide written informed consent prior to admission into the study.
You may not be if
1. 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;
2. have a history of drug or alcohol dependency or psychological disease;
3. have any clinically significant illness during the 4 weeks prior to admission into the study;
4. require regular use of medication that interferes with the absorption and/or metabolism of insulin;
5. 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;
6. use of Avandia or Actos for treating diabetes;
7. participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
8. use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
9. are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year;
11\. have a history of ketoacidosis;
12\. have any acute illness within 2 weeks prior to Screening; or,
13\. have elevated liver enzymes (ALT, AST, alkaline phosphatase) \>1.5 times the upper limit of normal.
