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A Pill for Type 1 Diabetes? Two New Studies Investigate SGLT-2 Inhibitor Jardiance

Published: 12/1/15
26 readers recommend
By Cheryl Alkon

Twitter Summary: Trials assess the safety and effectiveness of SGLT-2 inhibitor empagliflozin (Jardiance)

We’re bringing you a double trial watch — two clinical studies assessing the safety and effectiveness of the pill Jardiance (aka empagliflozin, an SGLT-2 inhibitor) in adults with type 1 diabetes. SGLT-2 inhibitors work by causing the kidneys to excrete excess glucose through the urine; they are a unique drug class in that they work independently of insulin.

Why is this new/important:

Jardiance is currently approved in the US for type 2 diabetes, but not type 1. These phase 3 studies are collecting additional data on the safety and effectiveness of Jardiance for type 1 diabetes. There has been a lot of excitement around Jardiance due to the recent groundbreaking evidence that it can reduce heart failure and death from heart disease for people with type 2 diabetes at high risk for heart disease. While it is not known whether these benefits apply to people with type 1 diabetes, the potential for A1c reductions, weight loss, lower blood pressure, and flatter glucose profiles could make the drug an appealing option for many people. Indeed, some people with type 1 diabetes already take Jardiance or other SGLT-2 inhibitors “off-label,” though this is generally not recommended due to the lack of safety information available. The advantage of SGLT-2 inhibitors is that they are glycemic dependent – that means they cause the user to urinate excess glucose when blood sugars are high, but they stop working when blood sugars are low. A major goal of these studies is to see how the benefits mentioned above stack up against risks like diabetic ketoacidosis, which may be a concern with this drug class in type 1 diabetes. 

The main difference between the two studies is trial length. You can find information on both trials below.

26-WEEK TRIAL

Clinical Trial Identifier: NCT02580591

Trial name: Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients with T1DM (EASE-3)

Diabetes type: Type 1 diabetes

What it’s testing: This trial will assess the efficacy, safety, tolerability, and pharmacokinetics (how a drug is metabolized by the body) of three doses of Jardiance as a supplement to insulin in people with type 1 diabetes.

Trial participants will receive a low, medium or high dose of Jardiance once-daily for 26 weeks, while continuing use of insulin multiple daily injections (MDI) or an insulin pump.

What the trial is measuring: This study is primarily focused on change in A1c, as well as other outcomes such as percent time spent in a target glucose range (70-180 mg/dl), and rates of hypoglycemia. More details here.

Trial Length: 26 weeks

Trial Location: The trial is currently recruiting in the following US states: CA, GA, MD, and TN. For a full list of current and future locations (including several European locations, Canada, and Australia), see here.

Do you qualify?

  • 18+ years old

  • Type 1 diabetes and used insulin for at least one year

  • A1c of 7.5% to 10%

  • Administering insulin via multiple daily injections (MDI) or insulin pump user with total daily insulin between 0.3 and 1.5 units per kilogram

  • Body Mass Index (BMI) greater than 18.5 (Calculate your BMI here)

Exclusion criteria include:

  • A history of type 2 diabetes

  • Past treatment for type 1 diabetes with any other glucose-lowering drug except basal and bolus insulin during the last three months

  • Severe hypoglycemia or diabetic ketoacidosis in the past three months

For a full list of inclusion and exclusion criteria see here.

Where to get more information: For more information, please go to the trial’s webpage and view the contact information specific to each enrolling location.

52-WEEK TRIAL:

Clinical Trial Identifier: NCT02414958

Trial name: Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes Over 52 Weeks (EASE-2)

Diabetes type: Type 1 diabetes

What it’s testing: This trial will assess the efficacy, safety, and tolerability of two doses of Jardiance in people with type 1 diabetes already on a multiple daily injection (MDI) insulin regimen. 

Trial participants will receive a high or low dose of Jardiance once daily for 52 weeks, while continuing use of multiple daily injections (MDI) or an insulin pump.

What the trial is measuring: This study is primarily focused on change in A1c, as well as other outcomes such as percent time spent in a target glucose range (70-180 mg/dl), and rates of hypoglycemia. More details here.

Trial Length: 52 weeks

Trial Location: The trial is currently recruiting in the following US states: CA, CO, FL, GA, ID, IL, IA, NE, NV, NH, NY, NC, OH, SD, TN, TX, UT, WA. For a full list of current and future locations, see here.

Do you qualify?

  • 18+ years old

  • Type 1 diabetes and used insulin for at least one year

  • A1c of 7.5% to 10%

  • Administering insulin via multiple daily injections (MDI) or insulin pump for the past five months

Exclusion criteria include:

  • A history of type 2 diabetes

  • Past treatment for type 1 diabetes with any other glucose-lowering drug except basal and bolus insulin during the last three months

  • Severe hypoglycemia or diabetic ketoacidosis in the past three months

For a full list of inclusion and exclusion criteria see here.

Where to get more information: For more information, please go to the trial’s webpage and view the contact information specific to each enrolling location. -CA

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