A Real World Experience of Dapagliflozin in Type 2 Diabetes

NCT02966626 | Completed

• 1 other identifier: 20163-2261
• Study Type: observational
• Target: 223
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Keywords

Pragmatic, Sodium-Glucose Transporter 2 inhibitor, Malaysia

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  To assess the change in HbA1c from baseline to 6 months

  6 months

Secondary Outcomes (4)

• Change in body weight

  6 months

• Change in estimated glomerular filtration rate

  6 months

• Change in albuminuria

  6 months

• Change in body mass index

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult T2DM patients who received at least one prescription for dapagliflozin for the first time between March 2014 and December 2015 at the University of Malaya Medical Center (UMMC) will be recruited. UMMC is an academic medical institution with 1,300 beds, serving a population of 1.8 million in Kuala Lumpur, Malaysia. The date of the first prescription for dapagliflozin in the Hospital Pharmacy Database is defined as the index date. Dapaglifozin is only available at the study site from March 2014 onwards.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Officials

• Lee Ling LIM, MRCP (UK)

  University of Malaya, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 17, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share