Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

Inclusion Criteria

• •Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl peptidase-4 (DPP-4) inhibitor or a sodium-glucose co transporter 2 (SGLT-2) inhibitor and who are not adequately controlled with this treatment.
• •Signed written informed consent.
• •Previous treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
• •History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons or lack of efficacy.
• •Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
• •Use of weight loss drugs within 3 months prior to screening.
• •Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
• •Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
• •Planned coronary, carotid, or peripheral artery revascularization procedures to be performed during the study period.
• •Known history of drug or alcohol abuse within 6 months prior to screening.
• •Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg.
• •Laboratory findings at screening visit (V1):
• •Amylase and/or lipase \>3 times the upper limit of normal (ULN) laboratory range.
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN.
• •Total bilirubin \>1.5 ULN (except in case of Gilbert's syndrome).
• •Calcitonin ≥20 pg/mL (5.9 pmol/L).
• •Hemoglobin \<10.5 g/dL and/or neutrophils \<1500/mm3 and/or platelets \<100 000/mm3.
• •Positive urine pregnancy test in female of childbearing potential.
• •Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or end-stage renal disease.
• •History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
• •Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
• •Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 \[Week -4\]).
• •HbA1c at V4 (Week -1) : \<7.0% or \>10%.
• •Fasting plasma glucose \>250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
• •Metformin maximal tolerated dose \<1500 mg/day.
• •Amylase and/or lipase \>3 ULN at V4 (Week-1).
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.