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:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT01499095
Eligibility Criteria:
Inclusion criteria :
* Participants with type 2 diabetes mellitus
* Substudy inclusion criteria:
* Completion of the 6-month study period in main study (Visit 10)
* Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)
Exclusion criteria:
* Age less than (\<) 18 years
* HbA1c \<7.0% or greater than (\>) 10% at screening
* Diabetes other than type 2 diabetes mellitus
* Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
* Participants using sulfonylurea in the last 2 months before screening visit
* Any contraindication to use of insulin glargine as defined in the national product label
* Use of insulin pump in the last 6 months before screening
* Initiation of new glucose-lowering medications in the last 3 months before screening visit
* History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
* Pregnant or breast-feeding women or women who intend to become pregnant during the study period
* Substudy exclusion criteria:
* Participant not willing to use the adaptable injection intervals on at least two days per week
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01499095
Study Brief:
Protocol Section:
NCT01499095