Clinical trial NCT03434119 (phase 3, status: terminated)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin glargine/lixisenatide, insulin glargine (hoe901), background therapy
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O
Reason stopped: 
    ("trial terminated (recruitment delays)")
  
Eligibility criteria:

        Inclusion criteria :

          -  Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to
             the screening visit (signing of informed consent).

          -  Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c
             (HbA1c) between 7.5% and 10% (inclusive).

          -  Participants who were Hispanics of any race, non-Hispanic black/African Americans or
             non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the
             participant's self-identification. Mixed-race participants must select 1 of the
             above-mentioned categories. If such selection could not be made, the candidate would
             be ineligible to participate in the study.

          -  Participants who had been treated with any basal insulin (ie, glargine - U100 or U300,
             detemir, degludec, intermediate-acting [human Neutral Protamine Hagedorn (NPH]) for at
             least 6 months prior to Visit 1.

          -  The basal insulin regimen (ie, type of insulin and time/frequency of the injection)
             had been stable for at least 3 months prior to Visit 1.

          -  The basal insulin dose had been stable (defined as up to ±20% [1/5 of the dose]
             variability) for at least 2 months prior to Visit 1 within the following dose ranges:

          -  15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (<=)8.5%, and

          -  15 to 40 units/day if HbA1c at Visit 1 is greater than (>)8.5%.

          -  Participants receiving 1 or 2 of the following OAD drugs: metformin,
             pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor
             or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1.

        Exclusion criteria:

          -  Age <18 years of age at Visit 1.

          -  A body mass index (BMI) <=20 or >40 kg/m^2 at Visit 1.

          -  Fasting plasma glucose (FPG) >200 mg/dL (by central lab measurement) at Visit 1
             (1-time repeat measurement before Visit 2 is permitted).

          -  Type 1 DM or any diabetes other than T2DM.

          -  Any use of OAD drugs other than those described in the inclusion criteria (e.g., but
             not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl
             peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1.

          -  Use of any other type of insulin except for basal insulin (e.g., prandial or premixed
             insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term
             treatment (i.e, <=10 days) with other insulin types due to intercurrent illness was
             permitted at the discretion of the Investigator.

          -  Known history of discontinuation of treatment with a GLP-1 RA due to
             safety/tolerability reasons.

          -  Use of systemic glucocorticoids for a total duration of >7 days within 12 weeks prior
             to Visit 1.

          -  Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit
             1.

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