Clinical trial NCT02058160 (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 (hoe901/ave0010), insulin glargine (hoe901), metformin (background drug)
SMILES: [V].[H][C@](C)(O)[C@]([H])(N=C(O)CN=C(O)[C@]([H])(CCC(O)=O)N=C(O)CN=C(O)[C@@]([H])(N)CC1=CN=CN1)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CC(O)=O)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCC(O)=N)C(O)=N[C@@]([H])(CCSC)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(C)C(O)=N[C@@]([H])(C(C)C)C(O)=N[C@@]([H])(CCCNC(N)=N)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CC1=CNC2=CC=CC=C12)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CO)C(O)=NCC(O)=N[C@@]([H])(C)C(=O)N1CCC[C@@]1([H])C(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N)[C@@]([H])(C)CC)[C@@]([H])(C)O, [Na+].[Na+].[O-]P([O-])(F)=O, CN(C)C(=N)NC(N)=N
Eligibility criteria:

        Inclusion criteria :

          -  Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.

          -  Treatment with basal insulin for at least 6 months before the screening visit.

          -  Stable basal insulin regimen (i.e. type of insulin and time/frequency of the
             injection) for at least 3 months before the screening visit.

          -  Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40
             Units/day for at least 2 months prior to the screening visit.

          -  For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs):
             the OAD dose(s) must be stable during the 3 months before the screening visit. The
             OADs could be 1 to 2 out of:

               -  metformin (more than or equal to 1500 mg/day or maximal tolerated dose),

               -  a sulfonylurea,

               -  a glinide,

               -  a dipeptidyl-peptidase-4 inhibitor,

               -  a sodium glucose co-transporter 2 inhibitor,

          -  Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening
             visit for participants receiving basal insulin in combination with 2 OADs or with 1
             OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at
             screening visit for participants on basal insulin only or basal insulin plus metformin
             at screening visit.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Age under legal age of adulthood at screening visit.

          -  HbA1c at screening visit less than 7.5% or above 10%.

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

          -  Use of other oral or injectable glucose-lowering agents than stated in the inclusion
             criteria in a period of 3 months prior to screening.

          -  Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in
             the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent
             illness is allowed.

          -  History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor
             Agonists for safety/tolerability or lack of efficacy.

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

          -  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 (eg, 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).

          -  Any contraindication to metformin use, according to local labeling, if the participant
             was taking metformin.

          -  Participant who had a renal function impairment with creatinine clearance less than 30
             mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for
             participants, not treated with metformin.

        Exclusion criteria for randomization:

          -  HbA1c less than 7% or above 10% .

          -  Mean fasting SMPG calculated from the self-measurements for 7 days the week before
             randomization visit was above 140 mg/dL (7.8 mmol/L).

          -  Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week
             before randomization visit).

          -  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.