NCT02688075已完成不适用
Prospective, Observational, 12-month Assessment of Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada (CANadian CAnagliflozin REgistry: CanCARE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Janssen Inc.
- 入组人数
- 538
- 主要终点
- Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months
研究概览
简要总结
The purpose of this study is to evaluate canagliflozin use in the treatment of type 2 diabetes mellitus (T2DM) and generate evidence of its effectiveness, safety and patient-reported outcome (PRO) in a usual clinical practice in Canada.
详细描述
This is a prospective, non-interventional, nation-wide, multicenter (more than one study site) study to evaluate the treatment of T2DM with canagliflozin in a usual clinical practice in Canada. Approximately 535 participants will be enrolled into this study. The planned study duration for each participant will be 12 months [plus or minus (+/-) 4 weeks], including 4 study visits in accordance with the usual clinical practice: enrollment and visits at 3, 6 and 12 months (+/- 4 weeks). Participants will primarily be observed for effectiveness, safety and PRO over an observational period of 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have a diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) of greater than or equal to (>=) 7 percent (%) at baseline
- •Participant must be on a stable antihyperglycemic treatment regimen for at least 30 days prior to canagliflozin initiation
- •Participant must have estimated glomerular filtration rate (eGFR) >=60 milliliter (mL)/minute(min)/1.73 meter^2 (m^2)
- •Must be a sodium-glucose co-transporter 2 (SGLT2) inhibitors naive participant initiating canagliflozin treatment prior to study enrollment
- •Participant must provide a written consent for data collection by signing an ICF indicating that they understand the procedures for data collection and are willing to participate in the study
排除标准
- •Participants with a history of SGLT2 inhibitors use (canagliflozin, empagliflozin, dapagliflozin or any other SGLT2 inhibitor)
- •Participants with a history of diabetic ketoacidosis (DKA), autoimmune diabetes (example, type 1 diabetes mellitus [T1DM] and latent autoimmune diabetes in adults [LADA]), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •Participants who received an investigational drug (including vaccines) within 3 months before the initiation of canagliflozin
- •Participant who is currently enrolled or plans to enroll in an investigational study
- •Participant who is pregnant or breastfeeding or planning to become pregnant or breast feed during the study
结局指标
主要结局
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months
时间窗: Baseline, Month 6 and 12
Mean HbA1c will be estimated.
次要结局
- Change From Baseline in Body Mass Index (BMI) at Month 3, 6 and 12(Baseline, Month 3, 6 and 12)
- Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 6.5 Percent (%)(Month 3, 6 and 12)
- Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%)(Month 3, 6 and 12)
- Percentage of Participants With Greater Than or Equal to (>=) 0.5% Reduction in Glycosylated Hemoglobin (HbA1c) Plus Weight Loss >=3%(Up to Month 12)
- Canagliflozin Treatment Adherence(Up to Month 12)
- Change From Baseline in Mean Weight at Month 3, 6 and 12(Baseline, Month 3, 6 and 12)
- Percentage of Participants With Weight Loss From Baseline at Month 3, 6 and 12(Baseline, Month 3, 6 and 12)
- Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 3, 6 and 12 Months by HbA1c Subgroup(Baseline, Month 3, 6 and 12)
- Change From Baseline in Waist Circumference at Month 3, 6 and 12(Baseline, Month 3, 6 and 12)
- Current Health Satisfaction Questionnaire (CHES-Q)(Up to Month 12)
- Number of Participants with Adverse Events (AEs) and Serious AEs(Up to Month 12)
研究者
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