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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01127269
Eligibility Criteria:
Inclusion criteria:
* Patients with a diagnosis of type 2 diabetes for more than 6 months
* Patients treated with Oral AntiDiabetics (OADs monotherapy or combination) with an HbA1c \>7% and \<10% and/or treated with NPH insulin with HbA1c \>7% and \<10% or treated with NPH insulin who have experienced severe and/or nocturnal hypoglycemia in the last 6 months.
* Ability to perform SMBS and insulin self-titration under the physicians guidance.
* Body Mass Index (BMI) \>21 kg/ m2.
* Signature of informed consent.
Exclusion criteria:
* Hospitalized patients.
* Pregnant women or with the intention of becoming pregnant.
* Unexplained weight loss of more than 10% in the last 6 months.
* Women with child bearing potential not using effective contraceptive methods.
* Women in breast feeding period.
* Patients on chronic treatment with systemic corticosteroids or protease inhibitors.
* History of drug or alcohol abuse.
* Diabetic retinopathy with surgical treatment in 3 months previous to study entry or patients that could require surgical treatment in the following 6 months to study entry.
* Major systemic disease clinically important that would interfere with implementation or interpretation of the study, at the discretion of the investigator.
* Renal failure known as creatinine \> 1.4 mg/dl in women and \> 1.5 mg/dl in men.
* Known hypersensitivity to glargine or any of its excipients.
* Patients with history of hospitalization due to cardiovascular event, cardiovascular procedure in the past 6 months.
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:
21 Years
Maximum Age:
80 Years
Study:
NCT01127269
Study Brief:
Protocol Section:
NCT01127269