Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin glargine/Lixisenatide; Insulin glargine (HOE901); Background therapy
Intervention description: Insulin glargine (100 units per milliliter [U/mL]) and lixisenatide (33 micrograms per milliliter [mcg/mL]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter [mmol/L]) while avoiding hypoglycemia.; Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.; Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Lixisenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c
           (HbA1c) change within the overall population.

        -  To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each
           ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African
           Americans and non-Hispanic Asians).

      Secondary Objective:

        -  To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy
           parameters within each ethnic/racial subgroup evaluated.

        -  To assess the change in daily insulin glargine dose within each ethnic/racial subgroup.

        -  To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua
           100/33 versus Lantus within each ethnic/racial subgroup.
    

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.