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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT02201004
Eligibility Criteria:
Inclusion criteria:
* Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
* Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
* Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
* Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
* Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
* Body mass index (BMI) ≥18.5 kg/m\^2 and \<35.0 kg/m\^2.
* No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.
Exclusion criteria:
* Type 1 diabetes mellitus.
* Pregnancy or lactation.
* Severely uncontrolled glycemic situation.
* History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
* History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
* A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
* Has previously received treatment with the investigational product.
* Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
* Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical \[skin\] application, eye drops and sprays).
* Patients who are frequently experiencing orthostatic hypotension.
* Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
* Lipid-lowering drug
* Antihypertensive drug
* Thyroid hormone preparation
* Uric acid lowering drug
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02201004
Study Brief:
Protocol Section:
NCT02201004