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NCT05345327: START
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Phase 3 trial testing Dapagliflozin in Type 2 Diabetes in 994 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | The George Institute |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 994 |
| Start date | 1 January 2023 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 8 locations across Sri Lanka, Australia |
Drugs / interventions tested
- Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
- Metformin (metformin) — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
The George Institute
Who can join
18 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
SGLT2 inhibitors: from glucose-lowering to cardiovascular benefits.
Preda A, Montecucco F, Carbone F, Carbone F, et al · · 2024 · cited 76× · PMID 38456601 · DOI 10.1093/cvr/cvae047
Verify or expand the search:
- PubMed search for NCT05345327
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT07239011 — Dapagliflozin in Depression · Phase 1, PHASE2 · recruiting
- NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other The George Institute trials
Trials by the same sponsor.
- NCT07231315 — INTERACT4 Expansion - Validation Study · not yet recruiting
- NCT04157231 — Essential Acute Stroke Care in Low Resource Settings: a Pilot studY · NA · not yet recruiting
- NCT06935760 — Optimised Treatment for Hypertension Trial · NA · not yet recruiting
- NCT06409364 — FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage · Phase 2 · recruiting
- NCT06058585 — The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05345327 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The George Institute
- Last refreshed: 20 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05345327.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing