A study to understand the Overall Insulin Usage Pattern in Insulin-Naive Type 2 Diabetes Mellitus (T2DM) Patients retrospectively
Not Applicable
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2021/03/031796
- Lead Sponsor
- Sanofi India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
• Male or female aged >= 18 years
• Patients with known case of type 2 diabetes mellitus
• Insulin naïve patients
• Treatment started with any type of insulin during the index period of 01 January 2016 to 31 December 2018
• Data of patients to be available for minimum of 6 months after starting insulin therapy
Exclusion Criteria
• Known case of type 1 diabetes mellitus, type 2 diabetes mellitus of <5 years duration, gestational diabetes and secondary diabetes (Eg. fibrocalculus pancreatic diabetes)
• Patients with cancer, end stage liver disease, end stage renal failure
• Treatment with short term insulin therapy ( < 1 month) and other investigational drugs concurrently during the retrospective data collection period
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To analyze the demographic profile of T2DM patients initiated on insulin (prior to insulin initiation)Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method â?¢To analyze the longitudinal outcomes in the subset of patients initiated on Glargine (U100 and U300).Timepoint: 12 months