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OpenTrials
Completed

NCT Number: NCT02966626

A Real World Experience of Dapagliflozin in Type 2 Diabetes

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in HbA1c

    Time frame: 6 months

    To assess the change in HbA1c from baseline to 6 months

Secondary outcomes

  1. Change in body weight

    Time frame: 6 months

    To assess the change in body weight from baseline to 6 months

  2. Change in estimated glomerular filtration rate

    Time frame: 6 months

    To assess the change in estimates glomerular filtration rate from baseline to 6 months

  3. Change in albuminuria

    Time frame: 6 months

    To assess the change in albuminuria from baseline to 6 months

  4. Change in body mass index

    Time frame: 6 months

    To assess the change in body mass index from baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 17, 2016
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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