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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00653302
Eligibility Criteria:
Inclusion Criteria:
* Known type 2 diabetes for at least 2 years
* No history of Ketoacidosis
* BMI\> 25 \& \<35 kg/m2
* Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
* With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
* and metformin at minimal posology 1700mg/day (1320 mg of metformin),
* HbA1c \>= 7.5 and \<11% for 2 different dosages during the last year
Exclusion Criteria:
* Type 1 diabetes
* Glucophage intolerability
* Pregnancy
* Breast feeding
* Partial pancreatectomy
* Hypersensitivity to insulin glargine excipient
* Renal failure with creatinin\>135 µmol/L for male and \>110 µmol/L for female patient
* Hepatitis with transaminases \>3ULN
* Pre-proliferative or proliferative retinopathy
* Acute cardiovascular accident within the last 6 months
* Previous treatment with insulin within the last 6 months before randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
69 Years
Study:
NCT00653302
Study Brief:
Protocol Section:
NCT00653302