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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT00666718
Eligibility Criteria:
Inclusion Criteria:
* Diabetes Mellitus, Type 2
* Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
* Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
* Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2
* Capable and willing to follow the protocol
* Give written consent
Exclusion Criteria:
* Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
* Have a history of severe hypoglycemia in the past 6 months
* Are pregnant or may become pregnant
* Women who are breastfeeding
* Have significant cardiac disease
* Have significant renal or liver disease
* Undergoing therapy for a malignancy
* Contraindications to the study medications
* Have an irregular sleep/wake cycle
* Have a serious disease or any condition considered by the investigator to be exclusionary
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00666718
Study Brief:
Protocol Section:
NCT00666718