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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Canagliflozin 300 mg

• Registration Number: NCT03604224
• Lead Sponsor: Johnson & Johnson Private Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2018-09-05
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Canagliflozin Containing Treatment Regimens	Canagliflozin 300 mg	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Dr. A. Ramachandran's Diabetes Hospitals; 🇮🇳 Chennai, India

Apollo Hospitals; 🇮🇳 Kolkata, India

Diacon Hospital; 🇮🇳 Bangalore, India