Health Condition 1: null- Type II Diabetes
Conditions
Interventions
Intervention1: Glaritus®: 3 mL cartridge, once daily SC injection in the medial aspect of the thigh or the abdomen for 12 months
Control Intervention1: Lantus®: 3 mL cartridge, once daily SC injecti
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: subject will be eligible for enrolment if, all of the following apply at the time of screening: 1. Male or Female Subjects >= 18 and 2. Subjects with body mass index (BMI) >=18.0 and 3. Subjects who have been diagnosed with T2DM. 4. Subjects with HbA1c levels >= 8% and 5. Subjects who are insulin naïve or may have received insulin for short term (=6 months prior to enrolment. 6. Subjects who are inadequately controlled by one or more OHAs and according to investigator needs glargine treatment as standard of care 7. Subjects who are co-operative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. 8. Ability to use the self-glucose-monitoring device and to selfadminister insulin and willing to record the daily FBG values and the insulin dose in a subject diary 9. Subjects who understand the nature of trial and provide written informed consent for the trial and the audio visual recording of the informed consent process
Exclusion criteria
Exclusion criteria: The subjects who meet, any of the following criteria at screening will not be eligible for enrolment in the study: 1. Women of child-bearing potential who are pregnant or lactating or not following adequate contraceptive measures. 2. Subjects with type 1 diabetes mellitus 3. Secondary diabetes or maturity-onset diabetes 4. History or evidence of allergy to insulin preparations 5. History or evidence of recurrent hypoglycemia 6. Currently receiving or has received any insulin therapy for more than 2 weeks within 6 months of enrolment. 7. 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. 8. History or evidence of nephropathy and/or neuropathy, significant cardiovascular disease, active severe proliferative retinopathy, renal dysfunction, hepatic dysfunction, any malignancy, thyroid dysfunction, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment. 9. History of Hepatitis B or C or human immunodeficiency virus (HIV) positive status 10. Undergone pancreatectomy or pancreas/islet cell transplant 11. A subject who has been treated with other investigational agent or devices within the previous 30 days. 12. Unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits 13. 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 |
|---|---|
| Percentage change in AIA titer to glargine in Glaritus® and Lantus® treatment arms from baseline to 6 monthsTimepoint: Screening, Month 3, month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in AIA titer to glargine in Glaritus® treatment arm from baseline to 12 monthsTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;Change in glycosylated haemoglobin (HbA1c) (%) from baseline to 6 months in both treatment armsTimepoint: baseline, 3 months, 6 months;Exploratory Endpoint: Change in HbA1c from baseline to 12 months in Glaritus® treatment armTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;Safety assessments including adverse events (AEs) (including hypoglycemia events), serious adverse events (SAEs), laboratory test results, electrocardiogram (ECG) findings, vital signs and physical examination findingsTimepoint: throughout study | — |
Countries
India
Contacts
Public ContactDr Sandesh V Sawant
Wockhardt Ltd.
Outcome results
None listed