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A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants with BMI greater than 25 kg/m2, in Real World Clinical Setting

Retrospective Observational Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Patients with BMI greater than 25 kg/m2, in Real World Clinical Setting

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/08/015481
Enrollment
500
Registered
2018-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Canagliflozin containing treatment regimen: No intervention will be administered as a part of this study. Participants with type 2 diabetes mellitus (T2DM) who were initiated on canagli

Sponsors

Johnson and Johnson Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: T2DM participants on a stable anti-hyperglycemic regimen containing one or more anti-diabetic drug for at least 30 days and had HbA1c of more than 7 percent at the time of, or within 2 weeks before canagliflozin 300 mg initiation T2DM participants as confirmed from hospital records T2DM participant having BMI greater than 25kg/m2 at the time of canagliflozin 300 mg initiation Participants having clinical assessment data (at least glycated haemoglobin A1c [HbA1c] and body weight) for at least two visits, that is (i.e.) visit at which treatment with canagliflozin 300 mg was initiated or 2 weeks before initiation and follow-up visit at 12 weeks (+-4 weeks) from initiation, in accordance with the usual clinical practice

Exclusion criteria

Exclusion criteria: Participants with history of autoimmune diabetes (type 1 diabetes mellitus [T1DM] or latent autoimmune diabetes in adults [LADA]), pancreas or betacell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or gestational diabetes or any off-label use or patient data refusal based on physician discretion Participants with a history of use of other Sodium Glucose co-Transporter 2 (SGLT2) inhibitor within 12 weeks (empagliflozin or dapagliflozin)

Design outcomes

Primary

MeasureTime frame
Change From Baseline in Mean Hemoglobin A1c (HbA1c) Change in mean HbA1c from baseline to 12 weeks will be determined. HbA1c refers to glycated haemoglobin (A1c), which identifies average plasma glucose concentration. Change From Baseline in Mean Weight Change in mean body weight from baseline to 12 weeks will be determinedTimepoint: Baseline up to 12 weeks Baseline up to 12 weeks

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Prashant Narang

Johnson and Johnson Private Limited

pnarang1@its.jnj.com

Outcome results

None listed

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