A Type 2 Diabetes Pill for Type 1 Diabetes?
Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page.
Clinical Trial Identifier: NCT02460978
Trial name: Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT 2)
Diabetes type: Type 1 diabetes.
What it’s testing: This one-year research study will test the addition of Farxiga (dapagliflozin) to insulin therapy in people with type 1 diabetes. Farxiga is currently approved as a once-daily pill for type 2 diabetes. However, it is considered investigational as used in this study. This trial will add important longer-term data on this drug class in type 1; if it is positive, AstraZeneca might seek approval.
What the trial is measuring: The trial will test Farxiga’s effect on A1c and changes in daily insulin dosing, body weight, the percent of time spent in range (between 70 and 180 mg/dl) using CGM readings, and the proportion of participants who achieve at least a 0.5% reduction in A1c without experiencing severe hypoglycemia.
Why this is new/important: SGLT-2 inhibitors (Farxiga, Invokana, and Jardiance) are approved for type 2 diabetes and come as a convenient once-daily pill. They work independent of insulin, meaning they can also help people with type 1 diabetes lower their blood glucose. The drug class blocks the reabsorption of glucose in the kidney. Basically, that means that people with diabetes who take this drug are peeing out extra glucose. SGLT-2 inhibitors only work when glucose levels are high and stop working when they are low (this is called “glucose dependent”). In addition to A1c reduction, SGLT-2 inhibitors often cause weight loss, reductions in blood pressure, and come with less risk of hypoglycemia than insulin. Side effects can include yeast and other infections and frequent urination.
Some people with type 1 diabetes take SGLT-2 inhibitors “off-label” already, though there have been some concerns of risks of “euglycemic diabetic ketoacidosis” or “euglycemic DKA”: a dangerous condition where ketoacidosis occurs even at a normal blood glucose level. Read more here for insights from renowned endocrinologist Dr. Anne Peters on the use of SGLT-2 inhibitors in people with type 1 diabetes and how to mitigate risks of euglycemic DKA.
We encourage everyone with diabetes to work carefully with their healthcare provider on all their therapies – and regardless of taking any off-label drugs, it’s important to be able to understand what appropriate ketone levels are and to know how to test them, though access to ketone meters remains a challenge for many.
Trial Length: Up to 68 weeks.
Trial Location: The trial is located at 140 different locations, including sites in the states of AZ, CA, CO, DE, FL, GA, IL, KS, KY, MN, MO, NV, NM, NY, PA, TX, VT, WA, as well as international locations in Argentina, Belarus, Belgium, Canada, Chile, Germany, Japan, the Netherlands, Poland, the Russian Federation, Sweden, Switzerland, and the United Kingdom.
Do you qualify?
Type 1 diabetes
18 to 75 years old
A1c between 7.7% and 11.0%
Insulin use for at least one year
If on MDI, must do at least three daily injections
Must have had a total daily insulin dose of over 0.3 U/kg in the past three months
Exclusion criteria include:
History of type 2 diabetes
Taking any other diabetes medication (other than insulin) within one month of screening
History of diabetic ketoacidosis, Addison’s disease severe hypoglycemia (requiring medical intervention), or hospitalization due to hyper/hypoglycemia within one month of screening