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

NCT ID: NCT00814294

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-09-30

Brief Summary

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.

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1; Placebo

Patients receive a sugar pill.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo capsule,0 units, quater in die (QID) for 18 weeks

2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Patients receive Oral HDV-Insulin (U-5).

Group Type: EXPERIMENTAL

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Intervention Type: DRUG

Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.

3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

Patients receive Oral HDV-Insulin (U-15).

Group Type: EXPERIMENTAL

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

Intervention Type: DRUG

Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.

Interventions

placebo

placebo capsule,0 units, quater in die (QID) for 18 weeks

Intervention Type: DRUG

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.

Intervention Type: DRUG

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diasome Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Len Rosenberg, PhD, RPh

Role: STUDY_DIRECTOR

Diasome Pharmaceuticals

David Orloff, MD

Role: STUDY_DIRECTOR

Medpace, Inc.

Locations

Muscle Shoals, Alabama, United States

Litchfield Park, Arizona, United States

Tucson, Arizona, United States

Concord, California, United States

Paramount, California, United States

Sacramento, California, United States

San Mateo, California, United States

Stockton, California, United States

Valley Village, California, United States

Walnut Creek, California, United States

Chiefland, Florida, United States

Fort Lauderdale, Florida, United States

Palm Harbor, Florida, United States

Pembroke Pines, Florida, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Topeka, Kansas, United States

Lexington, Kentucky, United States

Paducah, Kentucky, United States

Brockton, Massachusetts, United States

Picayune, Mississippi, United States

Omaha, Nebraska, United States

Staten Island, New York, United States

Cincinnati, Ohio, United States

Delaware, Ohio, United States

Zanesville, Ohio, United States

Beaver, Pennsylvania, United States

Kingsport, Tennessee, United States

Corpus Christi, Texas, United States

El Paso, Texas, United States

Houston, Texas, United States

Hurst, Texas, United States

Odessa, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Manassas, Virginia, United States

Virginia Beach, Virginia, United States

Renton, Washington, United States

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

DP 01-2007-03

Identifier Type: -

Identifier Source: org_study_id