Clinical trial NCT02058147 (phase 3, status: completed)
Conditions: type 2 diabetes
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin glargine/lixisenatide fixed ratio combination, insulin glargine (hoe901), lixisenatide (ave0010), metformin
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Eligibility criteria:

        Inclusion criteria:

          -  Participants with type 2 diabetes mellitus diagnosed for at least 1 year before the
             screening visit, treated for at least 3 months prior to visit 1 with metformin alone
             or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a
             glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4
             (DPP-4) inhibitors, and who were not adequately controlled with this treatment.

          -  Signed written informed consent.

        Exclusion criteria:

          -  HbA1c at screening visit:

               -  less than 7.5% or more than 10% for participants previously treated with
                  metformin alone,

               -  less than 7.0% or more than 9% for participants previously treated with metformin
                  and a second oral anti-diabetic treatment.

          -  Pregnancy or lactation, women of childbearing potential with no effective
             contraceptive method.

          -  Use of oral glucose-lowering agents other than those stated in the inclusion criteria
             or any injectable glucose-lowering agents during the 3 months before screening.

          -  Previous Treatment with insulin (except for short-term treatment due to intercurrent
             illness including gestational diabetes, at the discretion of the trial physician).

          -  History of discontinuation of a previous treatment with a glucagon-like peptide
             (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of
             efficacy.

          -  Participant who previously participated in any clinical trial with lixisenatide or the
             insulin glargine/lixisenatide fixed ratio combination or had previously received
             lixisenatide.

          -  Any contraindication to metformin use, according to local labeling.

          -  Use of weight loss drugs within 3 months prior to screening visit.

          -  Within the last 6 months prior to screening visit: history of stroke, myocardial
             infarction, unstable angina, or heart failure requiring hospitalization. Planned
             coronary, carotid or peripheral artery revascularisation procedures to be performed
             during the study period.

          -  History of pancreatitis (unless pancreatitis was related to gallstones and
             cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a
             previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.

          -  Personal or immediate family history of medullary thyroid cancer (MTC) or genetic
             conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).

          -  Uncontrolled or inadequately controlled hypertension (systolic blood pressure above
             180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.

          -  At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.

          -  At screening visit amylase and/or lipase more than 3 times the upper limit of the
             normal (ULN) laboratory range.

          -  At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more
             than 3 ULN.

          -  At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).

        Exclusion Criteria for randomization at the end of the screening period:

          -  HbA1c less than 7% or above 10%;

          -  Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);

          -  Metformin maximal tolerated dose less than 1500 mg/day;

          -  Amylase and/or lipase more than 3 ULN.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.