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

NCT00814294 | Completed Phase 2

• 1 other identifier: DP 01-2007-03
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 40

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.

Conditions

Diabetes

Keywords

Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  18 weeks

Secondary Outcomes (4)

• To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test

  18 weeks

• To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin

  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)

  18 Weeks

• To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels

  18 Weeks

Study Arms (3)

1; Placebo

PLACEBO COMPARATOR

Patients receive a sugar pill.

Drug: placebo

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

placebo DRUG

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

1; Placebo

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Diasome Pharmaceuticals: lead

Study Sites (40)

Unknown Facility

Muscle Shoals, Alabama, 35661, United States

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Litchfield Park, Arizona, 85340, United States

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Tucson, Arizona, 85712, United States

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Concord, California, 94520, United States

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Paramount, California, 90723, United States

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Sacramento, California, 95825, United States

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San Mateo, California, 94401, United States

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Stockton, California, 95204, United States

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Valley Village, California, 91607, United States

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Walnut Creek, California, 94598, United States

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Chiefland, Florida, 32626, United States

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Fort Lauderdale, Florida, 33308, United States

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Palm Harbor, Florida, 34684, United States

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Pembroke Pines, Florida, 33029, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30322, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40504, United States

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Paducah, Kentucky, 42003, United States

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Brockton, Massachusetts, 02301, United States

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Picayune, Mississippi, 39466, United States

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Omaha, Nebraska, 68114, United States

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Staten Island, New York, 10301, United States

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Cincinnati, Ohio, 45236, United States

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Delaware, Ohio, 43015, United States

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Zanesville, Ohio, 43701, United States

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Beaver, Pennsylvania, 15009, United States

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Kingsport, Tennessee, 37660, United States

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Corpus Christi, Texas, 78404, United States

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El Paso, Texas, 79935, United States

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Houston, Texas, 77074, United States

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Hurst, Texas, 76054, United States

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Odessa, Texas, 79761, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78237, United States

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Salt Lake City, Utah, 84124, United States

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Manassas, Virginia, 20110, United States

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Virginia Beach, Virginia, 23454, United States

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Renton, Washington, 98055, United States

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Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Len Rosenberg, PhD, RPh

  Diasome Pharmaceuticals

  STUDY DIRECTOR

• David Orloff, MD

  Medpace, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

US (40)