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:
NCT00870194
Eligibility Criteria:
Inclusion Criteria:
* Present with type 2 diabetes
* Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
* 100 mg/day sitagliptin and
* ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
* Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
* Have a body mass index (BMI) ≥20 kg/m2 and \<45 kg/m2
Exclusion Criteria:
* Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have previously completed or withdrawn from this study or any other study investigating exenatide.
* Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
* Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
* Are currently treated with any of the following excluded medications:
* Thiazolidinediones (TZD) within 3 months of screening.
* Sulfonylurea (SU) within 3 months of screening.
* Dipeptidyl peptidase-4 \[DPP-4\] inhibitors, with the exception of sitagliptin, within 3 months of screening.
* Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
* Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
* Exogenous insulin within the 3 months prior to screening.
* Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
* Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
* Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00870194
Study Brief:
Protocol Section:
NCT00870194