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

2019년 12월 29일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

201

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Simple random sample.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 전용
  • 시간 관점: 유망한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in the HbA1c level after 1 year
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in FPG level at 6months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • 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

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 2월 12일

기본 완료 (실제)

2018년 12월 31일

연구 완료 (실제)

2018년 12월 31일

연구 등록 날짜

최초 제출

2015년 9월 29일

QC 기준을 충족하는 최초 제출

2015년 10월 16일

처음 게시됨 (추정)

2015년 10월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 1월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 12월 29일

마지막으로 확인됨

2019년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • D1843R00258

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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