Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05570305
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
A Study to Assess the Effects of the Endothelin Receptor Antagonist Zibotentan and the SGLT2 Inhibitor Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria: a Randomized Double Blind Cross-Over Trial
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZODIAC
Brief Summary:
The aim of this study is to test the hypothesis that the effects on albuminuria of combination treatment with the endothelin receptor antagonist zibotentan and SGLT2i dapagliflozin are complimentary and additive while the fluid retaining effects of zibotentan can be mitigated by dapagliflozin.
Detailed Description:
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:
1. Zibotentan 1.5 mg once daily + Dapagliflozin 10 mg once daily.
2. Zibotentan 1.5 mg once daily.
3. Dapagliflozin 10 mg once daily.
4. Placebo once daily.
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:
1. Zibotentan 1.5 mg once daily + Dapagliflozin 10 mg once daily.
2. Zibotentan 1.5 mg once daily.
3. Dapagliflozin 10 mg once daily.
4. Placebo once daily.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-001324-18 | EUDRACT_NUMBER | None | View |