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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT03353350
Eligibility Criteria:
Inclusion criteria:
* Participants must be at least 18 years of age at the time of signing the informed consent.
* Participants with T2DM, and treated with diet and exercise.
* Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
Exclusion criteria:
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.
* History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
* Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
* Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
* Body weight change of ≥5 kg within the last 3 months prior to Screening.
* Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg at Randomization.
* End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease \[MDRD\]) of \<15 mL/min/1.73 m2.
* Laboratory findings at the Screening Visit:
* Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) \>3 times the upper limit of the normal (ULN ) or total bilirubin \>1.5 times the ULN (except in case of documented Gilbert's syndrome).
* Amylase and/or lipase: \>3 times the ULN laboratory range.
* Calcitonin ≥5.9 pmol/L (20 pg/mL).
* Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
* History of drug or alcohol abuse within 6 months prior to the time of Screening.
* Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
* Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.
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:
NCT03353350
Study Brief:
Protocol Section:
NCT03353350