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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 3
- 主要终点
- Change From Baseline in Mean Hemoglobin A1c (HbA1c)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Canagliflozin Containing Treatment Regimens
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.
干预措施: Canagliflozin 300 mg (Drug)
结局指标
主要结局
Change From Baseline in Mean Hemoglobin A1c (HbA1c)
时间窗: 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
时间窗: Baseline up to 12 weeks
Change in mean body weight from baseline to 12 weeks will be determined.
次要结局
未报告次要终点