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Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus on SGLT 2 Inhibitor Therapy in Singapore

2019年12月29日 更新者:AstraZeneca

SGLT2 Inhibitor Registry in Singapore

To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used hypoglycaemic drugs in real life clinical settings.

To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis in clinical practice setting. The study would also assess treatment patterns with SGLT2 inhibitor patient relevant outcomes in whole population as well as pre identified patient subgroups.

Primary analysis to be done at 1 year and extended analysis at 2 years.

研究概览

地位

完全的

条件

详细说明

T2DM is associated with overweight/obesity and high fasting plasma glucose (FPG) in White patients, whereas Asian patients are more predisposed to high abdominal fat distribution and high postprandial glucose (PPG) levels, thought to contribute1-4. In response to identical meals, Asian subjects exhibit greater glycemic response than do White subjects4,5. According to the Diabetic Society of Singapore, one out of nine people aged 18 to 69 has diabetes, that's about 11.3% of the population or more than 400,000 people & this is expected to rise with the increasing prevalence of a sedentary lifestyle and high-calorie dietary intake.

SGLT2 inhibitors offers a novel insulin-independent approach to lowering hyperglycaemia and improving metabolic control of type 2 diabetes: they reduce renal glucose reabsorption by inhibition of SGLT2 transporters in the proximal tubule of the kidney, resulting in urinary glucose excretion. Since SGLT2 inhibition is independent of β-cell function or insulin sensitivity, this treatment approach could have applications throughout the natural history of diabetes.6

The reductions in fasting plasma glucose concentration and bodyweight during the treatment with the SGLT2 i, are sustained. Early weight loss, is partly due to a mild osmotic diuresis caused by SGLT2 I, however, the gradual progressive reduction in bodyweight thereafter, with decreased waist circumference, is consistent with a reduction of fat mass. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, an effect supported by the increased urinary glucose/creatinine ratio in patients assigned to SGLT2i.6

Many trials shows that SGLT2 i can improve glycaemic control in patients who have inadequate control with metformin. The drug acts independently of insulin, lowers weight, and is not associated with risk of hypoglycaemia. Safety and tolerability of the drugs were also confirmed. Therefore, addition of SGLT2i to metformin provides a new therapeutic option for treatment of type 2 diabetes.6

Data collection will be done by AZ medical personnel or Pharmacy interns, it will be a paper data collection and will be handed over to the CRO company for data entry & analysis..Data analysis will be done by an independent CRO company namely BioQuest Solutions.

研究类型

观察性的

注册 (实际的)

201

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡
        • Research Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Simple random sample.

描述

Inclusion Criteria:

Patients should meet all of the following criteria at Day 0:

  • Outpatient equal to or more than 18 years of age
  • Diagnosed as T2DM and treated with antidiabetic medicines at least 3 months and suitable for SGLT2 inhibitor as current treatment judged by PI with HbA1c > 7.0 %
  • Will provide completed and signed written informed consents Each participating investigator, will be asked to recruit a fixed number of patients ranging from 10 to 40 depending on site specificities.

Exclusion Criteria:

Patients, with the following criteria will be excluded at Day 0:

  • Hypersensitivity to any SGLT2 inhibitor or any of the components in the formulation
  • Patients with Type 1 diabetes
  • Female patients with gestational diabetes during pregnancy
  • Female patients who are pregnant, intending to become pregnant or breastfeeding
  • Severe medical condition(s) that in the view of the investigator prohibits participation in the study e.g. cancer, end stage liver disease, end stage renal failure (non-diabetes related)
  • Use of other investigational drugs at the time of enrolment
  • Renal Function: <30ml/min/1.73m2

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:仅案例
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in the HbA1c level after 1 year
大体时间:baseline to 1 year
to assess whether the therapy initiated with SGLT2 inhibitors at baseline is able to reduce the HbA1c after 1 year.
baseline to 1 year

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in FPG level at 6months
大体时间:Blood samples are collected pre-dose, 6 months post-dose
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in FPG level at 12months
大体时间:Blood samples are collected pre-dose, 12 months post-dose
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in weight at 6months
大体时间:weight is measured pre-dose, 6 months post-dose
By assessment of the other weight reduction from baseline value to the last value
weight is measured pre-dose, 6 months post-dose
Change from baseline in weight at 12 months
大体时间:weight is measured pre-dose, 12 months post-dose
By assessment of the other weight reduction from baseline value to the last value
weight is measured pre-dose, 12 months post-dose
Change from baseline in BP at 6 months
大体时间:BP is measured pre-dose, 6 months post-dose
By assessment of the other BP reduction from baseline value to the last value
BP is measured pre-dose, 6 months post-dose
Change from baseline in BP at 12 months
大体时间:BP is measured pre-dose, 12 months post-dose
By assessment of the other BP reduction from baseline value to the last value
BP is measured pre-dose, 12 months post-dose
Change from baseline in Lipids at 6 months
大体时间:Blood samples are collected pre-dose, 6 months post-dose
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in Lipids at 12 months
大体时间:Blood samples are collected pre-dose, 12 months post-dose
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in Waist circumference at 6 months
大体时间:waist circumference is measured pre-dose, 6 months post-dose
By assessment of the other waist circumference reduction from baseline value to the last value
waist circumference is measured pre-dose, 6 months post-dose
Change from baseline in Waist circumference at 12 months
大体时间:waist circumference is measured pre-dose, 12 months post-dose
By assessment of the other waist circumference reduction from baseline value to the last value
waist circumference is measured pre-dose, 12 months post-dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • REFERENCES 1. Wang JS, et al. Diabetes Metab Res Rev. 2011;27:79-84 2. Bonora E, et al. Diabetes Care. 2001;24:2023-2029 3. Peter R, et al. Diabet Med. 2006;23:990-995 4. Venn BS, et al. Diabet Med. 2010;27:1205-1208 5. Henry CJ, et al. Br J Nutr. 2008;99:840-845 6. Bailey CJ, et al. Lancet. 2010;375:2223-33

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年2月12日

初级完成 (实际的)

2018年12月31日

研究完成 (实际的)

2018年12月31日

研究注册日期

首次提交

2015年9月29日

首先提交符合 QC 标准的

2015年10月16日

首次发布 (估计)

2015年10月19日

研究记录更新

最后更新发布 (实际的)

2020年1月2日

上次提交的符合 QC 标准的更新

2019年12月29日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • D1843R00258

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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