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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT00393705
Eligibility Criteria:
Inclusion Criteria:
* Have type 2 diabetes (World Health Organization \[WHO\] classification).
* Are at least 30 years of age and less than 75 years of age.
* Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
* Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or
* Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter \[mmol/l\]).
* Have given written informed consent to participate in this study in accordance with local regulations.
Exclusion Criteria:
* Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion.
* Have a body mass index greater than 40 kilograms per meter squared (kg/m2).
* Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
* Have congestive heart failure.
* Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00393705
Study Brief:
Protocol Section:
NCT00393705