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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00541567
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18-70 years and BMI ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c \>7% and HbA1c\<10%).
Exclusion Criteria:
* Pregnancy
* Anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy
* History of myocardial infarction in the prior six months/ History of heart failure defined as New York Heart Association Functional Class I, II, III or IV/ History of symptomatic arrhythmia
* Active hepatic disease/ Any documented muscle disease
* History of multiple sclerosis/ Baseline history of tremors, ataxia, anxiety or dizziness
* Seizures within the last year, stroke, and transient ischemic attack/ Known history of schizophrenia, dementia, or bipolar disorder as defined by DSM IV criteria.
* Currently depressed subjects or a CES-D score greater or equal to 16 at the screening visit or at baseline (Day 1)/ History of suicide attempt or ideation
* Previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ Weight loss greater than 5 kg in the prior 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00541567
Study Brief:
Protocol Section:
NCT00541567