Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2)
- Sponsor
- Steno Diabetes Center Copenhagen
- Study ID
- NCT03504566
- Phase
- PHASE4
- Status
- Withdrawn
Conditions
- Diabetic Nephropathy Type 2
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Linagliptin — DRUGLinagliptin
- Empagliflozin — DRUGEmpagliflozin
- Telmisartan — DRUGTelmisartan
- Sulodexide — DRUGSulodexide
Study Details
This project is an intervention study where type 2 diabetic patients will rotate through 4 different albuminuria lowering drugs with the aim to 1) quantify the individual relationship between drug exposure and albumin lowering response of different albuminuria lowering drugs in type 1 and type 2 diabetics; and 2) to investigate the effect of the same drug intervention on the glycocalyx layer in blood vessels. The overall purpose of this study is to allow for future personalized treatment of diabetics with regards to treating kidney disease more effectively than current standardized strategies.
Key Dates
- Start date
- Nov 15, 2017
- Status verified
- Sep 2018
- Primary completion
- Jun 1, 2019
- Completion
- Jun 1, 2019
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: InterventionAll patients recieve, in randomomized order a four way treatment schedule. Due to the nature of the study, the individual patient will serve as his/hers own comparator.
Primary Outcome Measure
Strongest albuminuria-lowering effect. [ Time Frame: 48 weeks ]