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

Study Overview
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Brief Summary
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A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.

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

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin | 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 | 3 weeks | 
| Daily glucodynamic profile of Oral HDV-Insulin | To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Type 1 and Type 2 Diabetes