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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00913367
Eligibility Criteria:
Inclusion Criteria:
* Patients over 20 years old with type 2 DM
* Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.
* 7%\<HbA1c\<11 % at screening
* 21 kg/m2 ≤ BMI ≤ 30 kg/m2
* Patents who need insulin add-on therapy based on investigator's discretion
* Patients who would give the informed consent
* Patients who can perform SMBG and record the data on the patient's diary
Exclusion Criteria:
* History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
* Pregnant or lactating females
* History of drug or alcohol abuse
* Patients with known hypersensitivity to glimepiride, metformin HCL or insulin
* Night-shift workers
* Patients who are under insulin therapy at screening
* Treatment with any investigational products in the last 3 months before screening
* Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision
* Patients with serum creatinine level \> 1.5 mg/dl in male and \> 1.4 mg/dl in female
* Patients with ALT or AST \> 3x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00913367
Study Brief:
Protocol Section:
NCT00913367