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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT02688933
Eligibility Criteria:
Inclusion criteria:
* Adult participants (male and female) with type 1 diabetes mellitus (T1DM).
* Signed written informed consent.
Exclusion criteria:
* Age \<18 years or \>70 years.
* Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.
* Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.
* Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening.
* Participants who experienced \>1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.
* Participants received less than 1 year treatment with basal plus mealtime insulin.
* Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.
* Required \>80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.
* Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.
* Used human regular insulin as mealtime insulin within 30 days prior to screening.
* Used an insulin pump during the last 6 months before screening.
* History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.
* Pregnant or breast-feeding women or planned pregnancy during the duration of the study.
* Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening.
* Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.
* Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.
The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02688933
Study Brief:
Protocol Section:
NCT02688933