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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT01204593
Eligibility Criteria:
Inclusion criteria:
1. Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:
* continuous subcutaneous insulin infusion (CSII, or pump), and
* patients already treated with insulin glargine
2. Age: 18-60 years inclusive
3. HbA1c: 8% - 10% assessed over the past 6 month
4. At least 1 year of continuous insulin treatment
5. Willingness to accept, and ability to follow:
* a basal bolus regimen (glargine x1 and glulisine x3 per day),
* self-monitoring blood glucose (SMBG)
* a fixed meal plan, or CHO counting
6. Signed informed consent obtained prior to any study procedure
Criteria for entry in the treatment period:
1. HbA1c 8-10% assessed between week -2 and week 0
2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
4. Pregnancy test negative if women of childbearing potential
Exclusion criteria:
1. History of hypersensitivity to insulin glargine and/or insulin glulisine
2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
3. Brittle diabetes
4. Known impaired renal function defined as serum creatinine \> 135 micromol/L in men and \> 110 micromol/L in women at study entry
5. Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry
6. Diabetes ketoacidosis
7. History of drug or alcohol abuse
8. Psychiatric or mental disease
9. Inclusion in another study in the past 6 months or previous inclusion in this study
10. Patient unable or unwilling to manage properly the basal bolus regimen
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:
60 Years
Study:
NCT01204593
Study Brief:
Protocol Section:
NCT01204593