A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients must satisfy all of the following inclusion criteria to be included in the study:
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be male or female between the ages of18 and 65 years, inclusive;
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have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
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have a current physical examination that reveals no clinically significant abnormalities;
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have no clinically significant abnormalities in vital signs;
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have a body mass index (BMI) <38;
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have a glycosylated hemoglobin (HbA1c) > 8 and <12;
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have a C-peptide level >3 ng/mL;
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have a typical fasting blood glucose levels of < 200 mg/dl (+/- 25 mg/dl);
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be available for the entire study period, and be able and willing to adhere to protocol requirements;
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if female of childbearing potential, must be using a reliable form of birth control; and,
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provide written informed consent prior to admission into the study.
Exclusion Criteria:
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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;
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have a history of drug or alcohol dependency or psychological disease;
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have any clinically significant illness during the 4 weeks prior to admission into the study;
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require regular use of medication that interferes with the absorption and/or metabolism of insulin;
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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;
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use of Avandia or Actos for treating diabetes;
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participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
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use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
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are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year;
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have a history of ketoacidosis;
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have any acute illness within 2 weeks prior to Screening; or,
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have elevated liver enzymes (ALT, AST, alkaline phosphatase) >1.5 times the upper limit of normal.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Antonio | Texas | United States |
Sponsors and Collaborators
- Diasome Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DP 01-2007-01