Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Approximately 27 weeks including a 24-week treatment period.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with type 2 diabetes mellitus diagnosed for at least 1 year.
Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.
You may not be if
Age \< legal age of adulthood (18 years).
Screening HbA1c \<7% or \>10%.
Screening FPG \>250 mg/dL (\>13.9 mmol/L).
Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
Type 1 diabetes mellitus.
Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
Use of insulin within the last 6 months.
Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN) at screening.
Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
Alanine Transferase (ALT) \>3 ULN 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).
Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure \>180 mmHg or \>110 mmHg, respectively.
Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
Body Mass Index (BMI) ≤20 or \>40 kg/m\^2.
Any previous treatment with lixisenatide
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
