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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT02941367
Eligibility Criteria:
Inclusion criteria :
* Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug.
* Patients who express the intention to fast during Ramadan.
* Signed informed consent.
Exclusion criteria:
* At the time of screening age \< legal age of majority.
* Glycated hemoglobin (HbA1c) at screening visit: \<7.5% or \>10%.
* Body mass index (BMI) \<20kg/m\^2.
* Treatment with basal insulin for less than 6 months prior to screening.
* Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and \<20% dose change) in the last 8 weeks prior to screening.
* Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening.
* Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
* Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided.
* Type 1, gestational or secondary diabetes.
* History of diabetic ketoacidosis.
* History of hypoglycemia unawareness.
* Any medical contraindication for sustained and safe fasting.
* Pregnant or breast-feeding women.
* Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients.
* All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.
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:
NCT02941367
Study Brief:
Protocol Section:
NCT02941367