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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00875394
Eligibility Criteria:
Inclusion Criteria:
* Patient Has Type 2 Diabetes Mellitus
* Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
* Patient Is Currently On Metformin Therapy (1500 Mg/Day)
* Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With \>2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
* Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
* Patient Has An A1c of 6.5 % - 11.0%
Exclusion Criteria:
* Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
78 Years
Study:
NCT00875394
Study Brief:
Protocol Section:
NCT00875394