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Asian Diabetes Outcomes Prevention Trial

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 4

SUMMARY

The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (\>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 40

Healthy Volunteers: f

View:

• Type 2 diabetes for at least six months

• ≥ 40 years of age, men or women

• No known cardiovascular disease ( defined as known coronary stenosis \> 70%, reduced left ventricular ejection fraction \< 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)

• NT-proBNP \> 125 pg/mL

• Written informed consent

Locations

Other Locations

Singapore

Singapore General Hospital (SGH)

RECRUITING

Singapore

Contact Information

Primary

Serene Ng Miss

serene.ng.b.l@singhealth.com.sg

67042232

Backup

Salma Asali Miss

asali.salma@singhealth.com.sg

67042303

Time Frame

Start Date: 2019-07-01

Estimated Completion Date: 2034-06-30

Participants

Target number of participants: 2400

Treatments

Other: Intensive Treatment Group

High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy.

No_intervention: Control Group

Standard therapy where the use of SGLT2i at randomization is not encouraged but RAASi and beta-blockers (except for maximal dosage) are allowed. Prescription or up-titration of the study drugs listed under Intensive Treatment is not encouraged. If investigators/treating physicians feel that further prescription or up-titration is required, a thorough justification is mandatory. Unless there is clinically irrefutable reason, every attempt should be made to use other blood pressure lowering drugs than RAASi or beta-blockers, as well as glucose lowering drugs than SGLT2i, in the control group.

Related Therapeutic Areas

Type 2 Diabetes (T2D)

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