Background:
Diabetes is common among American Indian people and diabetic kidney disease is a common
complication. Kidney disease caused by diabetes can lead to the need for kidney replacement,
by dialysis or kidney transplant, and is also associated with higher risk of early death. A
new diabetes medicine called empagliflozin may slow kidney disease from type 2 diabetes.
Researchers want to learn if it protects the kidneys when used in very early stages of
diabetic kidney disease.
Objectives:
To see if empaglifozin delays kidney disease development.
Eligibility:
Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at
least 5 years
Design:
Participants will be screened with health questions, blood pressure, and blood and urine
tests.
Participants will have:
- Medical history
- Physical exam
- Blood, urine, and stool samples taken
- Scan of the kidneys and liver. Participants will lie on a table that slides into an MRI
machine. They will hold their breath for up to 20 seconds and the MRI machine will take
images of their kidneys and liver. They will then repeat this with a small device that
vibrates on their side.
- Kidney tests. A needle will be placed in a vein in each arm for 4 hours. Blood pressure
will be taken. Participants will drink several quarts of water and urinate every 20
minutes. Urine and blood samples will be collected. Two liquids will be injected into
their veins to measure kidney function.
- Photos of the back of the eyes
- Kidney biopsy. Participants will have a scan and get drugs to make them sleepy. Up to
four very small pieces of kidney will be removed by needle. After the biopsy
participants will be monitored for at least 4 hours.
- Nerve tests
Participants will take the study drug or placebo pill once a day. Participants will attend
for tests every twelve weeks and have more extensive kidney function tests once a year. After
3 years, participants will have another kidney biopsy and then stop taking the study drug.
They will have a final kidney function test 2 months later.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)