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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00521378
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : January 13, 2009
Information provided by:
Diasome Pharmaceuticals

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

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Type : Observational
Estimated Enrollment : 20 participants
Time Perspective: Prospective
Official Title: A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521378

United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Diasome Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00521378     History of Changes
Other Study ID Numbers: DP 01-2007-01
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009

Keywords provided by Diasome Pharmaceuticals:
Type 1 and Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases