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 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT01121835
Eligibility Criteria:
Inclusion criteria:
* Type 2 diabetes diagnosed for more than 1 year
* Insulin naïve
* Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months
* HbA1c ≥ 7.0 % and ≤ 10.5%
* Body mass index (BMI) ≤ 40 kg/m2
* Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary
* Willingness and ability to comply with the study protocol
* Signed informed consent obtained prior any study procedure
Exclusion criteria:
* Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to study entry
* Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
* Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake)
* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
* Hospitalized patient (except for routine diabetes check-up)
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry
* History of sensitivity to the study drugs or to drugs with a similar chemical structure
* Impaired renal function: creatinine clearance \< 60ml/min
* Impaired liver function (ALT, AST \> 3 x upper limit of normal range)
* Severe gastro-intestinal disease
* Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry
* Likelihood of requiring treatments during the study which are not permitted
* Treatment with an investigational product in the 30 days prior to study entry
* Alcohol or drug abuse within the last 5 years
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:
35 Years
Study:
NCT01121835
Study Brief:
Protocol Section:
NCT01121835