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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014