A clinical study to observe safety of insulin glargine after the marketing of drug
Phase 4
Completed
- Conditions
- Health Condition 1: null- Type I and II diabetes mellitus
- Registration Number
- CTRI/2015/05/005741
- Lead Sponsor
- G Life Sciences India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
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
Contraindication - hypersensitivity to the active substance or to any
of the excipients as mentioned in the local prescribing information
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of adverse events and serious adverse eventsTimepoint: Incidence rate of adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method Change in HbA1c from baseline to week 12 and <br/ ><br>week 24. <br/ ><br>Change in FBG from baseline to week 12 and <br/ ><br>week 24. <br/ ><br>Change in lipid profile from baseline to week 24 <br/ ><br>Overall assessment of safety and tolerability by <br/ ><br>the investigators <br/ ><br>Global assessment of effectiveness by the <br/ ><br>investigators <br/ ><br>Timepoint: 24 weeks