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

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

Interventional

Enrollment (Actual)

239

Phase

  • 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

    • 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

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
Intervention / Treatment
Placebo Comparator: 1; Placebo
Patients receive a sugar pill.
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).
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).
Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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

December 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (Estimate)

December 24, 2008

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

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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