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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT02919059
Eligibility Criteria:
Inclusion Criteria:
* T2DM subjects with uncontrolled glycaemia, based on HbA1c levels (10% ≥ HbA1c ≥ 7%) at Visit 1.
* Patients may be treated for \>3 months with a stable doses of metformin at optimal doses tolerated.
* Participants will be able to give and sign informed consent form.
* Age \> 18 years of either gender.
Exclusion Criteria:
* Patients with two or more different oral antihyperglycemic agents.
* HbA 1c levels \> 10%.
* Systolic BP \>160 mm Hg and/or diastolic BP \> 100 mm Hg before randomization.
* History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation or diabetes secondary to any condition.
* History of one or more severe hypoglycaemic episode within 6 months before screening.
* Myocardial infarction, unstable angina pectoris, congestive heart failure, life threatening arrhythmia, history of cerebrovascular accident within 3 months.
* Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl or eGFR \< 60 ml/min/1.73m2, at screening.
* Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
* Existence of any serious systemic disease
* Allergic history to the compounds of study medication
* Can not comply the study protocol or misunderstand the informed consent form
* Women of childbearing potential will be required to use a double-barrier method of birth control throughout study participation. Women who are surgically sterile or documented post-menopausal for at least 2 years are not considered to be of childbearing potential.
* Pregnant or breast-feeding or planning to become pregnant during the study.
* History of alcohol abuse (\>350 g/week) within 3 years before screening.
* Concurrent therapy with medications that could be affect glycaemia (e.g. corticosteroids) or disallowed therapy (e.g. digoxin).
* Investigational drug treatment within the past 4 months
* Concomitant psychiatric diseases and/or habit/abuse of psychoactive substances
* Predictable lack of co-operation
* Shifts workers
* Employees of the investigator or study centre.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02919059
Study Brief:
Protocol Section:
NCT02919059