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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01541956
Eligibility Criteria:
Inclusion Criteria:
* Chinese T2D patients who are inadequate controlled (6.5 %\< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),
Exclusion Criteria:
* Type 1 diabetes and secondary diabetes
* Acute metabolic diabetic complications within the past 3 months.
* Acute infections which may influence glucose level.
* Evidence of significant chronic diabetic complications,
* Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
* FPG \> 270 mg/dl (15 mmol/l)
* Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF)
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01541956
Study Brief:
Protocol Section:
NCT01541956