Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to observe clinical effectiveness of canagliflozin by mean haemoglobin A1c (HbA1C) and body weight changes from baseline to 12 weeks in Indian type 2 diabetes participants.
Interventions
Participants who are initiated on canagliflozin 300 mg will be observed. No study treatment will be administered as a part of this study.
Sponsors
Johnson & Johnson Private Limited
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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\>25kg/m\^2 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
* Participants with history of autoimmune diabetes (type 1 diabetes mellitus \[T1DM\] or latent autoimmune diabetes in adults \[LADA\]), pancreas or beta-cell 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Hemoglobin A1c (HbA1c) | Baseline up to 12 weeks | 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 | Baseline up to 12 weeks | Change in mean body weight from baseline to 12 weeks will be determined. |
Countries
India
Outcome results
None listed