Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)

This trial is a multicenter, open-label, randomized, parallel-group trial in patients with
Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin
glargine with that of Lantus®.

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.