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Type 2 diabetes mellitus (T2DM) is creating a health pandemic globally. Management of type 2 diabetes involves combination of lifestyle intervention and drug intervention, which includes sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes in 2014. This study will describe the characteristics of patients who are prescribed dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe their glycaemic control, weight, and renal function at baseline and during use of dapagliflozin.
The prevalence of type 2 diabetes among adults >18 years old is 17.5% in Malaysia, where half of them are undiagnosed. Diabetes also accounts for 14.5% of all-cause mortality worldwide, with close to half of the deaths are in subjects <60 years old. These highlight the importance of early diagnosis of disease, timely intervention with appropriate therapy, and treating type 2 diabetes patients to goal to prevent the development of complications.
Asian type 2 diabetes phenotypes are different than Caucasians, i.e. significant pancreatic beta-cell dysfunction, higher visceral adiposity, more vulnerable to cardio-renal complications. Although clinical trials of SGLT-2 inhibitors have been published, real-world data on the use of this new class of antidiabetic medication is still lacking, in particularly among Asians.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | To assess the change in HbA1c from baseline to 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | To assess the change in body weight from baseline to 6 months | 6 months |
| Change in estimated glomerular filtration rate | To assess the change in estimates glomerular filtration rate from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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All adult T2DM patients who received at least one prescription for dapagliflozin for the first time between March 2014 and December 2015 at the University of Malaya Medical Center (UMMC) will be recruited. UMMC is an academic medical institution with 1,300 beds, serving a population of 1.8 million in Kuala Lumpur, Malaysia.
The date of the first prescription for dapagliflozin in the Hospital Pharmacy Database is defined as the index date. Dapaglifozin is only available at the study site from March 2014 onwards.
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| Name | Affiliation | Role |
|---|---|---|
| Lee Ling LIM, MRCP (UK) | University of Malaya, Malaysia | Principal Investigator |
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| 6 months |
| Change in albuminuria | To assess the change in albuminuria from baseline to 6 months | 6 months |
| Change in body mass index | To assess the change in body mass index from baseline to 6 months | 6 months |