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:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02219750
Eligibility Criteria:
Inclusion Criteria:
* Men and women with type 2 diabetes.(World Health Organization classification) \> 20 years of age.
* Patients who have received stable doses of any OADs for at least 12 weeks prior to the screening visit.
* treatment with basal insulin plus OADs \>3 months with suboptimal glycemic control (HbA1c \>7%)
* FBG \<130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose \>0.7U/kg or had history of nocturnal hypoglycemia
* Patients who are willing and able to cooperate with study and give signed informed consent.
Exclusion Criteria:
* Patients with type 1 diabetes.
* History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.
* Patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit.
* Patients hypersensitive with insulin analog or its excipients.
* Patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation.
* Renal dialysis patients, patients with severe liver disease or congestive heart failure
* BMI \>40kg/m2
* Excessive insulin resistance (total daily insulin dose\>2.0unit/kg)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02219750
Study Brief:
Protocol Section:
NCT02219750