Mylan Insulin Glargine Study

Inclusion Criteria

• Written and signed informed consent needs to be provided by subjects or their legal representatives before starting any protocol-specific procedures.
• Male and female subjects between the ages of 18 to 65 years, both ages inclusive.
• Subjects with an established diagnosis of T1DM per ADA 2017 criteria who also fulfil the following criteria:
• Initiation of insulin treatment within 6 months of T1DM diagnosis
• Treatment with basal-bolus insulin therapy for at least 1 year before screening
• Fasting plasma C-peptide 1.5 times of upper limit of reference range at screening
• History of severe form of neuropathy or cardiac autonomic neuropathy, recorded while collecting subject history. Subject's with mild or moderate forms of neuropathy will be allowed.
• Subjects with a history of limb amputation as a complication of diabetes (at any time), or any vascular procedure during the 1 year prior to screening.
• History of diabetic foot or diabetic ulcers in the 1 year prior to screening.
• Any elective surgery requiring hospitalization planned during the study period.
• Clinically significant major organ disorder at the time of screening including:
• Uncontrolled hypertension, defined as stage 2 hypertension by Joint National Committee VII (even if therapy is ongoing, blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic).
• Uncontrolled hyperlipidemia (even if therapy is ongoing, LDL >160 mg/dL or triglycerides >500 mg/dL).
• Uncontrolled hyperthyroidism or hypothyroidism (subjects can be included if these conditions are controlled with thyroid hormones or anti-thyroid drugs).
• Impaired hepatic function (alanine transaminase [ALT] or aspartate transaminase [AST] value >2 times the upper limit of the reference range and/or serum bilirubin 1.5 times the upper limit of the reference range at the screening visit). Subjects with evidence of Gilberts disease may be included in the study if they have total bilirubin of 80% of the total bilirubin.
• History of a significant medical condition, such as:
• Clinically significant cardiac disease like unstable angina, myocardial infarction, grade 3 or 4 congestive heart failure (CHF) according to New York Heart Association criteria, valvular heart disease, cardiac arrhythmia requiring treatment, and pulmonary hypertension; during the year prior to screening.
• Stroke or transient ischemic attack (TIA) in the 6 months before screening.
• Subjects with major depressive illness in the last 3 years (those who have well-controlled depression for 3 months on a stable dose of antidepressants, with no major depressive episodes in the last 3 years, can be included, even if they are on medication), subjects with history of other severe psychiatric diseases (manic depressive psychosis [MDP], schizophrenia), which in the opinion of the investigator precludes the subject from participating in the study (recorded while collecting subject history).
• History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, sickle cell anemia, etc.).
• Subjects using the following in the 3 months prior to screening:
• Insulin pump therapy
• Any anti-diabetic drugs other than the study insulins allowed by the protocol.
• Moderate insulin resistance, defined as requiring insulin of ≥1.5 U/IU/kg/day.
• Subjects who have received ≥14 consecutive days of glucocorticoid therapy by oral, intravenous, inhaled or other routes that produce systemic effects within the past 1 year, or who have received steroids by any route (except intra-nasal, intra-ocular, and topical) within the 4 weeks immediately preceding screening.
• Subjects diagnosed as having cancer (subjects with history of basal cell carcinoma, carcinoma in situ or squamous cell cancer of skin, or in remission >5 years, will be allowed).
• Subjects who have donated blood or plasma in the 1 month prior to screening