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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Diasome Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Diasome Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00814294
First received: December 23, 2008
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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.

Condition Intervention Phase
Diabetes
Drug: placebo
Drug: Oral HDV-I
Drug: Oral HDV-Insulin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Diasome Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels [ Time Frame: 18 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: December 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Patients on metformin will remain on their stable dose and receive a sugar pill.
Drug: placebo
placebo capsule,0 units, QID for 18 weeks
Experimental: 2; Oral HDV-Insulin
Patients on a stable dose of metformin will receive Oral HDV-I.
Drug: Oral HDV-Insulin
Oral HDV-I; Caps; 5 U; QID for 18 weeks.
Experimental: 3; Oral HDV-Insulin
Patients on a stable dose of metformin will receive Oral HDV-I.
Drug: Oral HDV-I
Oral HDV-I Caps; 15 U; QID for 18 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814294

  Hide Study Locations
Locations
United States, Alabama
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Litchfield Park, Arizona, United States, 85340
Tucson, Arizona, United States, 85712
United States, 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
United States, Florida
Chiefland, Florida, United States, 32626
Ft. Lauderdale, Florida, United States, 33308
Palm Harbor, Florida, United States, 34684
Pembroke Pines, Florida, United States, 33029
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30322
United States, Kansas
Topeka, Kansas, United States, 66606
United States, Kentucky
Lexington, Kentucky, United States, 40504
Paducah, Kentucky, United States, 42003
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
United States, Mississippi
Picayune, Mississippi, United States, 39466
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, New York
Staten Island, New York, United States, 10301
United States, Ohio
Cincinnati, Ohio, United States, 45236
Delaware, Ohio, United States, 43015
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, 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, 78237
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84124
United States, Virginia
Manassas, Virginia, United States, 20110
Virginia Beach, Virginia, United States, 23454
United States, Washington
Renton, Washington, United States, 98055
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Diasome Pharmaceuticals
Investigators
Study Director: Len Rosenberg, PhD, RPh Diasome Pharmaceuticals
Study Director: David Orloff, MD Medpace, Inc.
  More Information

No publications provided

Responsible Party: Len Rosenberg, President, Disaome Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00814294     History of Changes
Other Study ID Numbers: DP 01-2007-03
Study First Received: December 23, 2008
Last Updated: June 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Diasome Pharmaceuticals:
Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014