Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00814294
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00814294
Study Brief:
Protocol Section:
NCT00814294