Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria

Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria

A double-blind randomized placebo controlled cross-over study will be conducted in male and female subjects with type 2 diabetes aged between 18 and 75 years, urinary albumin:creatinine ratio (UACR) levels between 100 and 3500 mg/g, and an eGFR ≥ 30 ml/min/1.73m2 will be enrolled. Patients with type 1 diabetes or non-diabetic kidney disease will be excluded.
The study will consist of a screening visit, a 4-week (up to a maximum of 16-weeks) run-in phase for those subjects not on stable ACEi/ARB treatment. Subjects will be randomly assigned to one of two treatment orders. Each treatment order consists of three treatment periods, separed separated by 4-week wash-out period. Treatment period 1 and 2 take four weeks. The third treatment period last 6 weeks.
Participants will be randomized to treatments in addition to receiving background local standard of care (SoC) therapy as follows:

Zibotentan 1.5 mg once daily + Dapagliflozin 10 mg once daily.
Zibotentan 1.5 mg once daily.
Dapagliflozin 10 mg once daily.
Placebo once daily.

Source: View full study details on ClinicalTrials.gov

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October 21, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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