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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00917267
Eligibility Criteria:
Inclusion Criteria:
* Have been diagnosed with type 2 diabetes.
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
* Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive.
* Have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start).
* Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.
Exclusion Criteria:
* Have any contraindication for the OAD(s) that they use.
* Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
* Have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
* Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
* Have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start:
* Insulin
* Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
* Pramlintide acetate
* Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
* Have had prior exposure to exenatide
* Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are currently enrolled in any other clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00917267
Study Brief:
Protocol Section:
NCT00917267