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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01517412
Eligibility Criteria:
Inclusion criteria:
* Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
* Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.
Exclusion criteria:
* Screening HbA1c \< 7.0% and \> 10.0%
* Fasting plasma glucose at screening \> 250 mg/dL (\> 13.9 mmol/L)
* Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
* Participants who usually did not eat breakfast
* Type 1 diabetes mellitus
* Body Mass Index (BMI) ≤ 20 kg/m\^2 and \> 40 kg/m\^2
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
* Amylase and/or lipase \> 3 times the upper limit of the normal laboratory range ( ULN) at screening
* Alanine aminotransferase (ALT) \> 3 ULN at screening
* Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
* Any contra-indication related to metformin
* Any previous treatment with lixisenatide
The above information was 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:
NCT01517412
Study Brief:
Protocol Section:
NCT01517412