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OpenTrials
Completed

NCT Number: NCT03604224

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diacon Hospital, Bangalore, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Canagliflozin 300 mg

Drug

Participants who are initiated on canagliflozin 300 mg will be observed. No study treatment will be administered as a part of this study.

Primary outcomes

  1. Change From Baseline in Mean Hemoglobin A1c (HbA1c)

    Time frame: 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.

  2. Change From Baseline in Mean Weight

    Time frame: Baseline up to 12 weeks

    Change in mean body weight from baseline to 12 weeks will be determined.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Private Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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