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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00957060
Eligibility Criteria:
Inclusion criteria:
* Subject naïve to treatment
* HbA1c \> 8.5 up to 11 %
* Lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing
Exclusion criteria:
* Treatment with any oral antidiabetics or insulin
* Known type 1 Diabetes Mellitus
* Pregnant or breast feeding women
* Ketoacidosis history
* History of sensitivity to any of the active substances
* Renal dysfunction : serum creatinine \> or = 1.5 mg/dL in male subjects \> or = 1.4 mg/dL in female subjects
* Liver impairment (ALT, AST \> 3-fold the upper limit of normal range)
* Systemic corticosteroid treatment 3 months prior to study or during the study
* Drug or alcohol abuse history
* Patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
* Presence of any condition (medical, psychological, social or geographic) current or previously seen that according to Investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
* Neoplasias
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:
18 Years
Maximum Age:
70 Years
Study:
NCT00957060
Study Brief:
Protocol Section:
NCT00957060