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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521378
• Other study ID #: DP 01-2007-01
• Status: Completed
• Start date: September 17, 2007
• Est. completion date: October 6, 2007

Study information

• Verified date: May 2021
• Source: Diasome Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 6, 2007
• Est. primary completion date: October 6, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diasome Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Daily glucodynamic profile of Oral HDV-Insulin	To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days	3 weeks