A Real World Experience of Dapagliflozin in Type 2 Diabetes

Completed

• Conditions: Type2 Diabetes

• Registration Number: NCT02966626
• Lead Sponsor: University of Malaya

Brief 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.

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Study Start: 2017-01
• Primary Completion: 2017-09
• Study Completion: 2018-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months	To assess the change in HbA1c from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Change in body weight	6 months	To assess the change in body weight from baseline to 6 months
Change in estimated glomerular filtration rate	6 months	To assess the change in estimates glomerular filtration rate from baseline to 6 months
Change in albuminuria	6 months	To assess the change in albuminuria from baseline to 6 months
Change in body mass index	6 months	To assess the change in body mass index from baseline to 6 months