Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

This trial is a multi-center, open-label, randomized, parallel group trial in patients with
T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.
Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the
selection criteria will be included in the trial. This will be followed by a 24-week
randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine
or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there
will be a follow-up visit; 4 weeks after the patient has been put back on approved
medications.

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.