Health Condition 1: null- Type-1 Diabetes.
Conditions
Interventions
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
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects, who at the time of screening, have fasting C-peptide 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 >= 18 and 7. Ability to use the self glucose-monitoring device and to self administer insulin.
Exclusion criteria
Exclusion criteria: 1. A subject with impaired hepatic function, where liver enzymes (AST or ALT) levels are abnormal and are clinically significant as assessed by the Investigator, however not 3 times the upper limit of normal range. 2. A subject with impaired renal function, where serum creatinine 2.0 mg/dl and/or BUN 30 mg/dl. 3. A subject with serum AIA result 0.95 index value (i.e., â??Borderlineâ?? or â??Positiveâ??). 4. A subject who is Hepatitis B or C or HIV positive. 5. A subject who is in a hyperthyroid or hypothyroid state will be excluded from the study. However, earlier diagnosed subjects (with a history of hyperthyroidism or hypothyroidism) who are well controlled on treatment (Euthyroid) can be considered for enrollment in the study. 6. A Subject whose requirement for total daily dose of insulin is 1.4 units/kg. 7. A subject with history or evidence of allergy to insulin preparations. 8. A subject with history or evidence of recurrent severe hypoglycemia. 9. A subject who has received any insulin of animal origin during the last 3 years. 10. A subject who is currently receiving or has received, within the last year, any immunomodulator medications, including corticosteroids that would possibly modify antibody generation either at the enrollment or during the course of the study. Topical / ophthalmic / intra-articular / nasal spray corticosteroids will be allowed. 11. A subject who has received an oral hypoglycaemic agent within 4 weeks prior to screening. 12. A subject with history or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment. 13. A subject who has undergone pancreatectomy or pancreas/islet cell transplant. 14. A subject who has been treated with other investigational agent or devices within the previous 30 days. 15. A subject who is unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits. 16. A subject who is an employee of the Investigator, or a subject who has a direct involvement with the trial or other trials under the direction of the Investigator. 17. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1cTimepoint: Baseline End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in dose between 2 arms.Timepoint: Between randomization to end of trial.;SafetyTimepoint: Through out the trial | — |
Countries
India
Contacts
Public ContactDr Kiran Kumar Reddy
Vimta Labs Ltd.
Outcome results
None listed