A Real World Experience of Dapagliflozin in Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966626
• Other study ID #: 20163-2261
• Status: Completed
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: October 2018
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	To assess the change in HbA1c from baseline to 6 months	6 months
Secondary	Change in body weight	To assess the change in body weight from baseline to 6 months	6 months
Secondary	Change in estimated glomerular filtration rate	To assess the change in estimates glomerular filtration rate from baseline to 6 months	6 months
Secondary	Change in albuminuria	To assess the change in albuminuria from baseline to 6 months	6 months
Secondary	Change in body mass index	To assess the change in body mass index from baseline to 6 months	6 months