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Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2)

NCT03504566 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-09-14

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Nephropathy Type 2

Interventions

DRUG

Linagliptin

Linagliptin

DRUG

Empagliflozin

Empagliflozin

DRUG

Telmisartan

Telmisartan

DRUG

Sulodexide

Sulodexide

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-06-01
Completion
2019-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504566 on ClinicalTrials.gov