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

December 29, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Simple random sample.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the HbA1c level after 1 year
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in FPG level at 6months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 29, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • D1843R00258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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