Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Mylan's insulin glargine; Lantus®
Intervention description: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.; For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily
      (both administered in combination with other anti-diabetic drugs) based on the change in
      HbA1c from baseline to 24 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill
             the following:

               -  Diagnosis established 1 year prior to screening

               -  Insulin-naïve OR

               -  On Lantus® once daily at stable dose (±15% variation in dose) for at least 3
                  months prior to screening

          -  Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).

          -  Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to
             screening; this information will be collected by patient interview during medical
             history.

          -  Hemoglobin ≥9.0 g/dL at screening

          -  Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve
             patients at screening.

        Exclusion Criteria:

          -  History of hypersensitivity to any of the active or inactive ingredients of the
             insulin/insulin analog preparations used in the trial, OR history of significant
             allergic drug reactions.

          -  History of use of animal insulin within the last 3 years, any insulin other than
             Lantus® within the last 3 months prior to screening, or use of biosimilar insulin
             glargine at any time prior to screening.

          -  Patients requiring basal-bolus insulin therapy or who in the opinion of the
             investigator require mealtime insulin in order to achieve glycemic control.

          -  Regular use of immune-modulator therapy in the 1 year prior to screening.

          -  History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or
             history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I)
             as judged by the investigator.

          -  History of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for
             uncontrolled diabetes leading to hospitalization within the 6 months prior to
             screening.

          -  Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or
             hepatitis C (HCVAb) antibodies at screening.

          -  History of drug or alcohol dependence or abuse during the 1 year prior to screening.

          -  Receipt of another investigational drug in the 3 months prior to screening (or as per
             local regulations), or if the screening visit is within 5 half-lives of another
             investigational drug (whichever is longer), or scheduled to receive another
             investigational drug during the current trial period.