A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting

Johnson & Johnson (J&J)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Canagliflozin 300 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT03604224

28431754DIA4030 (Other Identifier)

CR108507

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

178 participants in 1 patient group

Canagliflozin Containing Treatment Regimens

Description:

No intervention will be administered as a part of this study. Participants with type 2 diabetes mellitus (T2DM) who were initiated on canagliflozin 300 milligram (mg) treatment 12 weeks back and meeting the inclusion criteria will be observed.

Treatment:

Drug: Canagliflozin 300 mg