Health Condition 1: null- Type I and II diabetes mellitus
Conditions
Interventions
Intervention1: Recombinant Insulin Glargine: The recommended starting
dose in patients with type 1
diabetes should be
approximately one-third of the
total daily insulin requirements.
The recommended s
Sponsors
LG Life Sciences India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with type I or type II diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia according to the clinical judgement of the physician. Willing and able to give informed consent.
Exclusion criteria
Exclusion criteria: Contraindication - hypersensitivity to the active substance or to any of the excipients as mentioned in the local prescribing information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events and serious adverse eventsTimepoint: Incidence rate of adverse events and serious adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to week 12 and week 24. Change in FBG from baseline to week 12 and week 24. Change in lipid profile from baseline to week 24 Overall assessment of safety and tolerability by the investigators Global assessment of effectiveness by the investigators Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactGoutam Bhattacharya
LG Life Sciences India Pvt. Ltd.
Outcome results
None listed