A Real World Experience of Dapagliflozin in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dapaglifozin in Type 2 Diabetes Mellitus Patients: A Single-centre Retrospective Cohort Study

Conditions
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Type2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T2DM prior to the first prescription of dapagliflozin Patients with T2DM who are initiated with dapagliflozin from March 2014 till December 2015 Patients need to be on dapagliflozin therapy for at least six consecutive months from the index date Patients need to have diabetologists/endocrinologists' follow up for at least six months after the initiation of dapagliflozin Exclusion Criteria: Patients with T2DM who are initiated with dapagliflozin after December 2015 Patients with incomplete electronic medical records Patients with Type 1 diabetes Patients with latent autoimmune diabetes of adults (LADA) Female Patients with T2DM who are found to be pregnant during the treatment period of dapagliflozin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | To assess the change in HbA1c from baseline to 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic, Sodium-Glucose Transporter 2 inhibitor, Malaysia