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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01281605
Eligibility Criteria:
Inclusion Criteria:
Patients must meet all of the following criteria:
1. Men and women with type 2 diabetes.
2. 20 years of age.
3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
4. Patients with inadequate glycemic control (HbA1C \>=7% and \< 11%).
5. Patients who are willing and able to cooperate with study and give signed informed consent.
Exclusion Criteria:
1. Patients with type 1 diabetes.
2. Renal dialysis patients.
3. History of hypoglycemia unawareness.
4. Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
5. Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
6. Patients hypersensitive with insulin detemir or its excipients.
7. Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01281605
Study Brief:
Protocol Section:
NCT01281605