Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Diabetes
In brief
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.
Key facts
- Study ID
- NCT00814294
- Run by
- Diasome Pharmaceuticals
- People needed
- 239
- Starts
- 2008-12-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2021-05-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
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;
- 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.
Where it is running
- Study site — Muscle Shoals, Alabama, United States
- Study site — Litchfield Park, Arizona, United States
- Study site — Tucson, Arizona, United States
- Study site — Concord, California, United States
- Study site — Paramount, California, United States
- Study site — Sacramento, California, United States
- Study site — San Mateo, California, United States
- Study site — Stockton, California, United States
- Study site — Valley Village, California, United States
- Study site — Walnut Creek, California, United States
- Study site — Chiefland, Florida, United States
- Study site — Fort Lauderdale, Florida, United States
- Study site — Palm Harbor, Florida, United States
- Study site — Pembroke Pines, Florida, United States
- Study site — Atlanta, Georgia, United States
- Study site — Atlanta, Georgia, United States
- Study site — Topeka, Kansas, United States
- Study site — Lexington, Kentucky, United States
- Study site — Paducah, Kentucky, United States
- Study site — Brockton, Massachusetts, United States
- Study site — Picayune, Mississippi, United States
- Study site — Omaha, Nebraska, United States
- Study site — Staten Island, New York, United States
- Study site — Cincinnati, Ohio, United States
- Study site — Delaware, Ohio, United States
Full record on ClinicalTrials.gov
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