Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Mylan's insulin glargine; Lantus®
Intervention description: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.; All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
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: 558.0
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
      (based on change in HbA1c from baseline to 24 weeks) when administered in combination with
      mealtime insulin lispro.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with an established diagnosis of T1DM per ADA 2014 criteria

          -  Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).

          -  Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.

          -  Hemoglobin ≥9.0 g/dL at screening.

        Exclusion Criteria:

          -  History of hypersensitivity to any of the active or inactive ingredients of the
             insulin/insulin analogue preparations used in the trial, OR history of significant
             allergic drug reactions.

          -  History of use of animal insulin within the last 3 years or use of biosimilar insulin
             glargine at any time prior.

          -  History of use of a regular immunomodulator 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 episodes of diabetic ketoacidosis 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.