A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin glargine, 300 U/ml; Insulin glargine, 100 U/ml; Insulin detemir; Background Therapy
Intervention description: Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness
      Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (<8% if age >=65 years
      or with defined comorbidities or otherwise <7%) at 6 months without documented symptomatic
      (Blood Glucose <=70 mg/deciliter [mg/dL]) and/or severe hypoglycemia at any time of day from
      baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes
      initiating basal insulin therapy in a real world setting.

      Secondary Objectives:

      Compare Toujeo to other commercially available basal insulins at 6 months after initiating
      insulin therapy in a real world setting in terms of:

        -  Participant persistence with assigned basal insulin therapy.

        -  Risk of hypoglycemia including the incidence and rate of documented symptomatic and
           severe hypoglycemia.

        -  Changes in HbA1c, fasting plasma glucose, body weight

        -  Differences in participant and provider- reported outcomes (including Diabetes Treatment
           Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia
           Patient Questionnaire, and participant and provider reported Global Effectiveness Scale
           (GES).

        -  Healthcare resource utilization including hospitalizations and emergency department or
           other provider visits and healthcare costs.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with Type 2 Diabetes Mellitus (T2DM), as defined by the American Diabetes
             Association/World Health Organization, diagnosed for at least 1 year at the time of
             the screening visit, insufficiently controlled after at least 1 year of treatment with
             2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones,
             dipeptidyl peptidase-4 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2)
             inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily
             use with insulin (Victoza, Byetta, Adlyxin).

          -  Adult patients who have signed an Informed Consent Form and Health Insurance
             Portability and Accountability Act (HIPAA) Authorization Form.

        Exclusion criteria:

          -  HbA1c <8.0% or >11.0%.

          -  Males or females <18 years of age.

          -  Type 1 diabetes mellitus.

          -  Any clinically significant abnormality identified on physical examination, laboratory
             tests, or vital signs at the time of screening, or any major systemic disease
             resulting in short life expectancy that in the opinion of the Investigator would
             restrict or limit the participant's successful participation for the duration of the
             study.

          -  Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog,
             Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than
             temporary use during pregnancy or hospitalization, or short-term use during acute
             event.

          -  Use of oral hypoglycemic agents other than those noted in the inclusion criteria,
             GLP-1 receptor agonists for weekly use, or any investigational agent (drug, biologic,
             or device) within 3 months prior to the time of screening.

          -  All contraindications to commercially available insulin therapy or
             warnings/precautions of use as displayed in the respective national product labeling
             for these products.

          -  Pregnancy or lactation.

          -  Women of childbearing potential with no effective contraceptive method.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.