An observational study in Type2 Diabetes, sponsored by University of Malaya. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-12.
Sponsored by University of Malaya · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 223 is close to the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Change in HbA1c
To assess the change in HbA1c from baseline to 6 months
Time frame: 6 months
Change in body weight
To assess the change in body weight from baseline to 6 months
Time frame: 6 months
Change in estimated glomerular filtration rate
To assess the change in estimates glomerular filtration rate from baseline to 6 months
Time frame: 6 months
Change in albuminuria
To assess the change in albuminuria from baseline to 6 months
Time frame: 6 months
Change in body mass index
To assess the change in body mass index from baseline to 6 months
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Malaya