Participate in Research at CU Anschutz

In this study, we are trying to assess if taking a medication called ertugliflozin can improve outcomes for patients with type 2 diabetes. In this study, we look at how effective ertugliflozin is in people with type 2 diabetes on blood pressure and kidney function. We compare the effect of ertugliflozin with the effect of a placebo (“dummy pill”). We also look at whether the effects depend on the amount of salt that participants take in their diet.

If you choose to participate, you will take the study medication, ertugliflozin, or placebo over 4 so-called treatment blocks of 20 days each. You will be recommended foods based on a sodium-controlled diet for approximately 23 weeks. There will be 5 study visits total over 23 weeks, which will involve the study procedures listed below. Visit 1: Screening visit (~2 hrs): Obtain consent Review medications and medical history Physical exam, height, weight, and vital signs Collect blood and urine samples for lab tests Discuss study diet recommendations Electrocardiogram (ECG) Provide 24-hour urine and blood pressure cuff Treatment period: Take one pill of ertugliflozin or placebo per day for 10 days (for each of the 4 treatment blocks). Each of the 4 treatment blocks is 20 days. The first 10 days is a strict sodium diet, then the last 10 days is the same sodium diet plus the daily study medication. Long visits (4 visits total, ~5 hours each) Collect blood & urine samples for lab tests Renal Clearance Test Kidney MRI Medical history and vitals In between visits: Collect 24-hour urines (5 times) Wear blood pressure monitoring device (5 times) Telephone calls (4 times) Total Compensation of the DESIGN Study is $950.00