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NCT04304430: DARWIN-FUP
Comparative Effectiveness of Dapagliflozin Versus DPP-4 Inhibitors
trial testing Dapagliflozin in Type 2 Diabetes in 11,206 participants. Completed in 29 February 2020.
26 December 2019
Quick facts
| Lead sponsor | University of Padova |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 11,206 |
| Start date | 18 October 2018 |
| Primary completion | 26 December 2019 |
| Estimated completion | 29 February 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
- DPP-4 inhibitor — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
University of Padova
Who can join
Adults 18 to 80, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Owing to their glycemic and extraglycemic effects, sodium glucose cotransporter-2 inhibitors (SGLT2i) are becoming ideal second-line agents for the treatment of type 2 diabetes (T2D). However, SGLT2i are not devoid of side effects. Because of glycosuria, SGLT2i increase the risk of genito-urinary tract infections (GUTI) and may favour dehydration or volume depletion, especially in patients taking diuretics. In addition, SGLT2i can precipitate diabetic ketoacidosis (DKA), especially when used off-label in type 1 diabetes or in T2D patients with poor beta cell function. Furthermore, based on final results of the cardiovascular outcome trials, a boxed warning was added to the canagliflozin label regarding an increase in the risk of amputations. For these reasons, although the cardiovascular benefits of SGLT2i are clearly delineating, their widespread use as second-line agents may be contended by other oral glucose lowering medications which are perceived to be provided with a more neutral safety profile, namely dipeptidyl peptidase-4 (DPP-4) inhibitors (DPP-4i). DPP-4i as a class lower HbA1c by 0.5-0.7% and exert minor or no effects on body weight, blood pressure, and lipid profile. In addition, three large randomized controlled trials (RCTs) showed no benefit of sitagliptin, saxagliptin, and alogliptin on cardiovascular outcomes, with an isolated signal that saxagliptin might increase the risk of hospitalization for heart failure. Importantly, observational retrospective studies has shown that the SGLT2i dapagliflozin, compared to DPP4i, is associated with lower risk of cardiovascular events and all-cause mortality. The present study aims at providing real world data on the comparative effectiveness of SGLT2i versus DPP-4i on a composite endpoint of HbA1c, body weight and blood pressure reduction. The study has the potential to demonstrate multiple benefits of SGLT2i in the routine clinical practice, as compared to DPP-4i, which are perceived to be safer but are mostly devoid of extraglycemic effects. We hypothesize that dapagliflozin is superior to DPP-4i in the attainment of a composite endpoint of HbA1c, body weight and blood pressure reduction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04304430
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Trials by the same sponsor.
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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 NCT04304430 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Padova
- Last refreshed: 11 March 2020
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/NCT04304430.
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