Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Type 1 and Type 2 Diabetes
Brief summary
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
Interventions
None listed
Sponsors
Diasome Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients must satisfy all of the following inclusion criteria to be included in the study: 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin | 3 weeks | To determine the dose response of postprandial plasma glucose to escalating doses (increased daily) of Oral HDV-Insulin given as single doses before breakfast, lunch and dinner, in addition to the Diabetes Mellitus (DM) subject's regular oral type 2 therapy |
| Daily glucodynamic profile of Oral HDV-Insulin | 3 weeks | To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days |
Countries
United States
Outcome results
None listed