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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT00546702
Eligibility Criteria:
Inclusion Criteria:
* Adult men and women (\>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40)
* An HbA1c range of \>6.5 - \<11%
* And on multiple injection regimen (more than 1 year of continuous insulin treatment)
* Body mass index \<35.
Exclusion Criteria:
* Active proliferative diabetic retinopathy
* Diabetes other than type I diabetes mellitus
* Pancreatectomised subjects
* Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine
* Hypersensitivity to insulin
* Major systemic diseases
* Impaired hepatic or renal function
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
Study:
NCT00546702
Study Brief:
Protocol Section:
NCT00546702