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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00664534
Eligibility Criteria:
Inclusion Criteria:
* Diabetes Mellitus, Type 2
* have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione \[TZD\]) without insulin, for at least 90 days prior to Visit 1
* glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
* regularly consume a light breakfast (less than 15% of total daily calorie intake)
* capable and willing to follow the protocol
* give written consent
Exclusion Criteria:
* are taking a TZD whose country label does not allow in combination with insulin
* are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
* have a body mass index greater than 40 kg/m\^2
* have a history of severe hypoglycemia in past 24 weeks
* 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 study medications
* have an irregular sleep/wake cycle
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
74 Years
Study:
NCT00664534
Study Brief:
Protocol Section:
NCT00664534