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:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT00789750
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Type 2 diabetes mellitus
* Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications \[metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor\]
* Hemoglobin A1c (HbA1c) \>= 7.5% and =\< 9.5% at screening
* Fasting plasma glucose =\<240 mg/dL at randomization (Week 0/Day 1).
* Male or female \>= 18 years of age.
* Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol
* Fasting C-peptide level \>0.5 ng/mL at screening
* Clinically stable in regards to medical conditions other than type 2 diabetes
* Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period
Exclusion Criteria:
* History of Type 1 diabetes and/or history of ketoacidosis
* History of bowel obstruction
* History of hypertriglyceridemia-induced pancreatitis
* Fasting serum triglyceride concentration \>500 mg/dL
* History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery
* History of insulin use \>= 2 weeks duration during the previous 3 months or a total of \>2 months insulin therapy at any time prior to screening
* Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening
* Female subject who is pregnant or breastfeeding
* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00789750
Study Brief:
Protocol Section:
NCT00789750