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A study to understand the Overall Insulin Usage Pattern in Insulin-Naive Type 2 Diabetes Mellitus (T2DM) Patients retrospectively

Retrospective EMR Database Study in India: Assessment of Overall Insulin Pattern in Insulin Naive T2DM Patients(REALITY)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/03/031796
Enrollment
1000
Registered
2021-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: NIL: NIL

Sponsors

Sanofi India Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Known case of type 1 diabetes mellitus, type 2 diabetes mellitus of • Patients with cancer, end stage liver disease, end stage renal failure • Treatment with short term insulin therapy (

Design outcomes

Primary

MeasureTime frame
To analyze the demographic profile of T2DM patients initiated on insulin (prior to insulin initiation)Timepoint: 12 months—

Secondary

MeasureTime frame
â?¢ To analyze the longitudinal outcomes in the subset of patients initiated on Glargine (U100 and U300).Timepoint: 12 months—

Countries

India

Contacts

Public ContactDr Romik Ghosh

Sanofi India Limited

romik.ghosh@sanofi.com02228032489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026