Increasingly, there is recognition that, for effective treatment of type 1 diabetes (T1D), insulin alone is not enough. People living with type 2 diabetes are treated with multiple medications to address the metabolic impacts of the disease. People living with T1D likely would benefit from a similar approach. The two trials highlighted below address the need for additional drugs to achieve optimal control for type 1 diabetes. Both trials are enrolling now in the PNW. Your participation can help drive progress towards a more comprehensive array of treatment options for people with T1D!
Are you struggling to manage low blood sugar from T1D? If so, you may be interested in joining the CATT1 study, now enrolling through the University of Washington in Seattle.
The CATT1 study will look at whether the study drug, cadisegliatin (also called TTP399), can reduce the frequency of low blood sugar (hypoglycemia) in adults with T1D. The study drug is a tablet taken by mouth. It is designed to stimulate the liver and improve the liver’s ability to store sugar from food, which may reduce episodes of high or low blood sugar.
You may be eligible for this study if you:
- Are 18 years of age or older
- Have had T1D for at least 5 years
- Have had at least one hypoglycemic event (blood sugar <54 mg/dL) in the last 2 months
Benefits of participating in this study include:
- Possible access to a study drug. Some participants will receive placebo, which has no active ingredients
- Study support and monitoring by a healthcare team
- Education about diabetes and hypoglycemia
- Compensation for your time and participation
- The opportunity to help advance T1D research
If you are interested in participating in the CATT1 study, please contact Darinka Gil dgm91@uw.edu
The SUGARNSALT study is still enrolling at the University of Washington (UW) in Seattle and Oregon Health & Science University (OHSU) in Portland. This study is looking to determine if an investigational oral medication, called Sotagliflozin (SOTA), can help slow kidney function decline in patients with T1D.
SOTA is a drug in the family of medications called sodium-glucose cotransporter-2 inhibitors (SGLT2i). SGLT2i drugs are now available for patients with type 2 diabetes to prevent or delay end-stage kidney disease. Whether these drugs have similar effects in patients with T1D remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA).
One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated in SOTA to very low levels.
In the present study, a similar DKA prevention program will be used to carry out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced diabetic kidney disease.
After a 2-month period, during which diabetes care will standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet.
Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those wo took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study.
If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and diabetic kidney disease.
You may be eligible for this study if you:
- Have been diagnosed with type 1 diabetes for at least 8 years and have been continuously treated with insulin
- Are 18-75 years old
- Have been told by your doctor that you have diabetic kidney disease or protein in your urine
If you are interested in participating in the SUGARNSALT study, please contact:
OHSU: Aly Carlson, 971-610-3005; Krista Metas, 971-484-5758, Email: sugarnsalt@ohsu.edu
UW: Paul Ly, lypaul@uw.edu
