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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01676233
Eligibility Criteria:
Inclusion criteria :
* Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;
Exclusion criteria:
* Age \< 20 years at written informed consent;
* HbA1c \< 6.5% or \> 10.0% at screening
* Diabetes mellitus (DM) other than T1DM;
* Body Mass Index (BMI) \> 35.0 kg/m2 at screening visit
* Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
* Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit
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:
20 Years
Study:
NCT01676233
Study Brief:
Protocol Section:
NCT01676233