Clinical Trials Directory

Trials / Completed

CompletedNCT02966626

A Real World Experience of Dapagliflozin in Type 2 Diabetes

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

Status
Completed
Phase
Study type
Observational
Enrollment
223 (actual)
Sponsor
University of Malaya · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Timeline

Start date
2017-01-01
Primary completion
2017-09-01
Completion
2018-01-01
First posted
2016-11-17
Last updated
2018-10-12

Source: ClinicalTrials.gov record NCT02966626. Inclusion in this directory is not an endorsement.