A Real World Experience of Dapagliflozin in Type 2 Diabetes
Dapaglifozin in Type 2 Diabetes Mellitus Patients: A Single-centre Retrospective Cohort Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in HbA1c
Tidsramme: 6 months
|
To assess the change in HbA1c from baseline to 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in body weight
Tidsramme: 6 months
|
To assess the change in body weight from baseline to 6 months
|
6 months
|
|
Change in estimated glomerular filtration rate
Tidsramme: 6 months
|
To assess the change in estimates glomerular filtration rate from baseline to 6 months
|
6 months
|
|
Change in albuminuria
Tidsramme: 6 months
|
To assess the change in albuminuria from baseline to 6 months
|
6 months
|
|
Change in body mass index
Tidsramme: 6 months
|
To assess the change in body mass index from baseline to 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lee Ling LIM, MRCP (UK), University of Malaya, Malaysia
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20163-2261
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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