Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus on SGLT 2 Inhibitor Therapy in Singapore
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational [Patient Registry]

Summary: 
      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.
    

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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Simple random sample.