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 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT01421459
Eligibility Criteria:
Inclusion Criteria:
* Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
* Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
* Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
* Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m\^2)
Exclusion Criteria:
* Have significant liver, cardiac or gastrointestinal disease
* Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
* Have an excessive resistance to insulin or hypersensitivity to Lantus
* Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
* Have taken any other insulin other than Lantus within the past 30 days
* Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01421459
Study Brief:
Protocol Section:
NCT01421459