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

This study has been completed.
Sponsor:
Information provided by:
Diasome Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00521378
First received: August 23, 2007
Last updated: January 10, 2009
Last verified: January 2009
  Purpose

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


Condition
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

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

Resource links provided by NLM:


Further study details as provided by Diasome Pharmaceuticals:

Estimated Enrollment: 20
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521378

Locations
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Diasome Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00521378     History of Changes
Other Study ID Numbers: DP 01-2007-01
Study First Received: August 23, 2007
Last Updated: January 10, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014