Observational, Prospective, Parallel Cohort Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea on a Background Therapy of Metformin With or Without a DPP-4 Inhibitor During Ramadan Fasting in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 主要终点
- Percentage of Participants With at Least one Episode of Hypoglycaemia
研究概览
简要总结
The primary purpose of this study is to describe the tolerability of canagliflozin and any sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms of the percentage of patients with at least one episode of hypoglycaemia, in patients with T2DM who fast during Ramadan.
详细描述
This is non-randomized, parallel-cohort, prospective, multicenter (when more than one hospital works on a medical research study), observational study to describe the treatment of T2DM with canagliflozin during the Holy Month of Ramadan. Observed participants will be participants with T2DM (at the time of enrollment) who are being treated with either canagliflozin or any sulphonylurea, each administered on a background therapy of metformin with or without a DPP-4 inhibitor within clinical practice, and who intend to fast during the Ramadan period. On enrollment, patients will enter one of two parallel treatment cohorts based on their ongoing T2DM therapy: canagliflozin and metformin with or without a DPP-4 inhibitor will be the treatment of interest, while any sulphonylurea and metformin with or without a DPP-4 inhibitor will serve as the reference standard treatment. Safety will be monitored throughout the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who has a confirmed diagnosis of type 2 diabetes for more than 12 months before enrollment
- •Participants who has been treated with canagliflozin or any sulphonylurea, each on a background therapy of metformin with or without a dipeptidyl peptidase 4 (DPP-4) inhibitor, for >12 weeks before enrollment
- •Participants Intends to fast during Ramadan in 2016
- •Participants Will be able to continue on the products under study (i.e., canagliflozin or any sulphonylurea, each with metformin with or without a DPP-4 inhibitor) through the Ramadan period, as judged by the participating physician
- •Participants who has a glycated hemoglobin (HbA1c) measurement less than and equal to (<=) 8.5% within 8 weeks before the start of Ramadan.
排除标准
- •Participant is being treated with insulin and/or any type 2 diabetes mellitus (T2DM) therapy other than canagliflozin, any sulphonylurea, and metformin with or without a DPP 4 inhibitor, or has changed their T2DM therapy within 12 weeks before enrollment (dose changes of canagliflozin, a sulphonylurea, metformin, and a DPP 4 inhibitor where applicable are accepted)
- •Participant is currently being treated with loop diuretics
- •Participants who has a history of severe hypoglycaemia events within the 6 months prior to enrollment (defined as a hypoglycaemia event for which the patient required assistance from another person, or which resulted in seizure or loss of consciousness).
- •Participants who has heart failure (NYHA 3-4) or advanced cardiovascular disease.
- •Participants who has an estimated glomerular filtration rate (eGFR) less than (<) 60 milliliter/minute (mL/min)/1.73 m^2.
结局指标
主要结局
Percentage of Participants With at Least one Episode of Hypoglycaemia
时间窗: during the Ramadan period (up to 1 month)
Hypoglycaemia events are defined by symptoms (e.g., dizziness, visual blurring, palpitations, nausea, sweating, confusion, tremor or intense hunger) reported by the patient in the patient diary, with confirmation by a physician where applicable; Episode may be documented via a self-monitored blood glucose measurement \<70 milligram/deciliter (mg/dl).
次要结局
- Number of Participants With Volume Depletion Events(during the Ramadan period (up to 1 month))
- Time to the First Hypoglycaemia Event(during the Ramadan period (up to 1 month))
- Relationship of Hypoglycaemia Events With Clinical Parameters(during the Ramadan period (up to 1 month))
- Relationship of Hypoglycaemia Events With Number of Fasting Days(during the Ramadan period (up to 1 month))
- Relationship of Volume Depletion Events With Clinical Parameters(during the Ramadan period (up to 1 month))
- Relationship of Volume Depletion Events With Treatment Adherence(during the Ramadan period (up to 1 month))
- Relationship of Volume Depletion Events With Number of Fasting Days(during the Ramadan period (up to 1 month))
- Relationship of Hypoglycaemia Events With Used Treatment(during the Ramadan period (up to 1 month))
- Relationship of Volume Depletion Events With Used Treatment(during the Ramadan period (up to 1 month))
- Treatment Adherence Based on the Percentage of Prescribed Doses of Canagliflozin or Sulphonylurea Taken by Participants(during the Ramadan period (up to 1 month))
- Relationship of Hypoglycaemia Events With Treatment Adherence(during the Ramadan period (up to 1 month))