Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus

May 24, 2021 updated by: Diasome Pharmaceuticals

An 18-Week Randomized, Double-Blind, Multicenter, Comparator Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus

The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment.

The secondary objectives are:

  • To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), frequency of hypoglycemic events, body weight, and lipid levels; and
  • To evaluate the safety and tolerability of oral HDV-I.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study with a washout/stabilization period of up to 12 weeks in duration and an 18-week double-blind treatment period. There will be a total of 8 visits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

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

  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
      • Tucson, Arizona, United States, 85712
    • California
      • Concord, California, United States, 94520
      • Paramount, California, United States, 90723
      • Sacramento, California, United States, 95825
      • San Mateo, California, United States, 94401
      • Stockton, California, United States, 95204
      • Valley Village, California, United States, 91607
      • Walnut Creek, California, United States, 94598
    • Florida
      • Chiefland, Florida, United States, 32626
      • Fort Lauderdale, Florida, United States, 33308
      • Palm Harbor, Florida, United States, 34684
      • Pembroke Pines, Florida, United States, 33029
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30322
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Kentucky
      • Lexington, Kentucky, United States, 40504
      • Paducah, Kentucky, United States, 42003
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
    • Mississippi
      • Picayune, Mississippi, United States, 39466
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New York
      • Staten Island, New York, United States, 10301
    • Ohio
      • Cincinnati, Ohio, United States, 45236
      • Delaware, Ohio, United States, 43015
      • Zanesville, Ohio, United States, 43701
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Corpus Christi, Texas, United States, 78404
      • El Paso, Texas, United States, 79935
      • Houston, Texas, United States, 77074
      • Hurst, Texas, United States, 76054
      • Odessa, Texas, United States, 79761
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78237
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Manassas, Virginia, United States, 20110
      • Virginia Beach, Virginia, United States, 23454
    • Washington
      • Renton, Washington, United States, 98055
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 70 years, inclusive;
  • Diagnosis of type 2 diabetes mellitus;
  • Fasting plasma glucose <=250 mg/dL;
  • BMI <=45 kg/m2;
  • HbA1c levels as follows at Screening:
  • On a stable dose of metformin monotherapy with an HbA1c >=7.5% and <=9.5%;
  • On metformin and 1 other OAD (excluding TZD, exenatide, or insulin) with an HbA1c >=6.8% and <=9.0%;
  • Naïve to antidiabetic therapy or have not been on a stable dose of metformin monotherapy for <12 weeks with an HbA1c >=8.0% and <=10.5%;
  • Understanding of the study procedures and agreement to participate in the study, giving written informed consent;
  • Women may be enrolled if all of the following criteria (in addition to the above criteria) are met:
  • They are not pregnant (women of childbearing potential must have a negative serum pregnancy test at Visit 1);
  • They are not breast-feeding;
  • They do not plan to become pregnant during the study; and
  • They have had a hysterectomy or tubal ligation 6 months prior to the study, have been post-menopausal for 1 year, or will practice a method of birth control throughout the study.

Exclusion Criteria:

  • History of type 1 diabetes and/or history of ketoacidosis;
  • History of chronic (>2 months) use of insulin therapy or recent initiation of insulin use intended for chronic administration;
  • Use of TZD (pioglitazone or rosiglitazone) or exenatide within 3 months prior to Screening;
  • Use of prescription or over the counter weight loss agents within 1 month prior to Screening;
  • Use of any lipid-altering, antihypertensive, and other chronic use medication not stable for 1 month prior to Screening;
  • Use of any medication that may alter blood glucose analyses;
  • Any serious disorder including cardiac, pulmonary, hepatic, uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
  • Require regular use of medication that interferes with the oral absorption and/or metabolism of insulin or metformin;
  • History of pancreatitis;
  • History of acquired immune deficiency syndrome or human immunodeficiency virus;
  • History of drug or alcohol abuse within the past 2 years;
  • Hospitalization for any cause within 14 days prior to the study;
  • History of an allergic or toxic response to oral HDV-I;
  • Uncontrolled hypertension: systolic blood pressure >160 mmHg and diastolic blood pressure >95 mmHg;
  • Triglycerides >400 mg/dL;
  • Aspartate aminotransferase or alanine aminotransferase >2.5 times the upper limit of normal (ULN);
  • Creatine phosphokinase >3 times the ULN;
  • Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of starting the study;
  • Use of any investigational drug within 30 days preceding the first dose of study medication; or
  • Employment by the research center.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 1; Placebo
Patients receive a sugar pill.
Drug: placebo
placebo capsule,0 units, quater in die (QID) for 18 weeks
Experimental: 2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Patients receive Oral HDV-Insulin (U-5).
Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.
Experimental: 3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
Patients receive Oral HDV-Insulin (U-15).
Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment.
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test
Time Frame: 18 weeks
18 weeks
To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin
Time Frame: 18 weeks
18 weeks
To evaluate the effects of oral HDV-I versus placebo on the homeostasis model assessment of insulin resistance (HOMA-IR)and homeostasis model assessment of β-cell function (HOMA-β)
Time Frame: 18 Weeks
18 Weeks
To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels
Time Frame: 18 Weeks
18 Weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diasome Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Len Rosenberg, PhD, RPh, 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DP 01-2007-03

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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