A Real World Experience of Dapagliflozin in Type 2 Diabetes

University of Malaya

Status: Completed

Conditions: Type2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT02966626

20163-2261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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