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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT01022658
Eligibility Criteria:
Inclusion Criteria:
* Consent patient
* Adults from 30 to 72 years old
* type 2 diabetic patients for at least 1 year
* able to self measure capillary blood glucose
* body mass index 20-37 kg/m²,
* HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months
* anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months
Exclusion criteria:
* pregnancy
* other antidiabetic medication in the previous 2 months,
* anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,
* insulin allergy,
* uncontrolled preproliferative or proliferative diabetic retinopathy
* uncontrolled hypertension
* renal failure(creatinin clearance \<40 ml/min)
* hepatocellular deficiency (prothrombin time \<70%)
* anemia
* peripheral occlusive arterial disease
* cardiac arrhythmia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
72 Years
Study:
NCT01022658
Study Brief:
Protocol Section:
NCT01022658