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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT00643851
Eligibility Criteria:
Inclusion Criteria:
* Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
* Drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis
* C-peptide ≥ 1.0 ng/mL
* Body Mass Index ≤ 45.0 kg/m
* Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women
Exclusion Criteria:
* AST and/or ALT \>3.0 times the upper limit of normal (ULN)
* Serum total bilirubin \> 2.0 mg/dL
* Creatine kinase \> 3X the upper limit of normal (ULN)
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
77 Years
Study:
NCT00643851
Study Brief:
Protocol Section:
NCT00643851