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

NCT00521378 | Completed

• 1 other identifier: DP 01-2007-01
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Diabetes; Type 1 and Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• Daily glucodynamic profile of Oral HDV-Insulin

  To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days

  3 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Study Population

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

You may qualify if:

• be male or female between the ages of18 and 65 years, inclusive;
• have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
• have a current physical examination that reveals no clinically significant abnormalities;
• have no clinically significant abnormalities in vital signs;
• have a body mass index (BMI) \<38;
• have a glycosylated hemoglobin (HbA1c) \> 8 and \<12;
• have a C-peptide level \>3 ng/mL;
• have a typical fasting blood glucose levels of \< 200 mg/dl (+/- 25 mg/dl);
• be available for the entire study period, and be able and willing to adhere to protocol requirements;
• if female of childbearing potential, must be using a reliable form of birth control; and,
• provide written informed consent prior to admission into the study.

You may not qualify if:

• 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;
• have a history of drug or alcohol dependency or psychological disease;
• have any clinically significant illness during the 4 weeks prior to admission into the study;
• require regular use of medication that interferes with the absorption and/or metabolism of insulin;
• 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;
• use of Avandia or Actos for treating diabetes;
• participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
• use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
• are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year;
• \. have a history of ketoacidosis;
• \. have any acute illness within 2 weeks prior to Screening; or,
• \. have elevated liver enzymes (ALT, AST, alkaline phosphatase) \>1.5 times the upper limit of normal.

Sponsors & Collaborators

• Diasome Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 27, 2007
• Study Start: September 17, 2007
• Primary Completion: October 6, 2007
• Study Completion: October 6, 2007
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

US (1)