A comparative safety and efficacy of insulin analogue glargine in Type-1 diabetes patients

INTERVENTION: Intervention1: Glaritus: Insulin analogue glargine manufactured by Wockhardt Ltd.. Starting Dose: 0.5 to 0.7 U/kg body weight; Dose can be titrated based on the fasting blood glucose levels; Frequency: Once daily at bedtime; Duration: 12 weeks of study period; Mode of administration: Subcuteneous; Control Intervention1: Lantus: Insulin analogue glargine manufactured by Sanofi ‐ Aventis. Starting Dose: 0.5 to 0.7 U/kg body weight; Dose can be titrated based on the fasting blood glucose levels; Frequency: Once daily at bedtime; Duration: 12 weeks of study period; Mode of administration: Subcuteneous; CONDITION: Type‐1 Diabetes. PRIMARY OUTCOME: Change in HbA1c‐‐‐‐‐‐Timepoint: Baseline ; End of trial SECONDARY OUTCOME: Change in dose between 2 arms.‐‐‐‐‐‐Timepoint: Between randomization to end of trial. Safety‐‐‐‐‐‐Timepoint: Through out the trial INCLUSION CRITERIA: 1. Subjects, who at the time of screening, have fasting C‐peptide < 0.5 nmol/L and have been on an insulin regimen for at least 12 months prior to inclusion in the trial. 2. Subjects with glycosylated hemoglobin (HbA1c) levels between 8 and 10%. 3. Subjects with body mass index (BMI) 18.0 to 38.0 kg/m2. 4. Subjects who understand nature of trial & provide written informed consent. 5. Subjects who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. 6. Female subjects who are not pregnant and not lactating. Females subjects of childbearing potential must agree to use an acceptable method of birth control (including barrierâ??method contraceptives or intrauterine device). Women with history of bilateral tubal ligation, women who have undergone total hysterectomy or women who are post‐menopausal for atleast 2 years are eligible (if within â?¥ 18