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

May 12, 2021 updated by: Diasome Pharmaceuticals
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

Have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin
Time Frame: 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
3 weeks
Daily glucodynamic profile of Oral HDV-Insulin
Time Frame: 3 weeks
To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diasome Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2007

Primary Completion (Actual)

October 6, 2007

Study Completion (Actual)

October 6, 2007

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP 01-2007-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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