A 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: NCT02384941

Diabetes Type: Type 1 diabetes.

What It’s Testing: This trial will test a new pill (an oral drug currently called LX4211 or sotagliflozin) to aid insulin therapy and improve blood glucose in people with type 1 diabetes. LX4211 blocks both SGLT-2 (found in the kidney) and SGLT-1 (found in the gut) transporter proteins, which work to reabsorb glucose in the body. By preventing both proteins from doing their job, this oral drug will cause less glucose to be absorbed through the gut and more glucose to leave the body through the urine, thus lowering blood glucose levels. This drug works independently of insulin and stops working when blood glucose reaches a low level (“glucose dependent”), making it a unique and promising option for managing blood glucose in patients with type 1 diabetes.

What the Trial is Measuring: This trial is measuring LX4211’s effects on A1c, body weight, bolus insulin dosage, and fasting plasma glucose compared to a placebo.

Why this is new/important: LX4211 – a pill – may help lower post-meal blood sugar spikes and thus require patients with type 1 diabetes to use less bolus insulin. LX4211 would also be the first SGLT-1/SGLT-2 inhibitor combination drug – currently, there are three SGLT-2 inhibitor drugs approved for type 2 diabetes. Though some type 1 patients take SGLT-2 drugs “off-label,” they are not officially FDA-approved for this purpose.

There have been past concerns that SGLT-1 inhibitor drugs might cause digestion issues because they target the gut, but so far in studies with the combination SGLT-1/SGLT-2 inhibitor LX4211, participants have not experienced any major side effects.

Trial Length: Approximately one year.

Do you qualify: To enter the trial, participants must be 18 years or older, have type 1 diabetes on insulin treatment with either insulin pump or MDI, and have an A1c at screening between 7% and 11%.

Trial Location: This trial is currently recruiting participants in five states: CA*, GA, KY, NC, and TX.

*While the clinicaltrials.gov site does not mention it, we have been told the trial is also recruiting participants in the Los Angeles area – for information on joining the LA trial, please contact Dr. Juan Frias at [email protected]

Where to Get More Information: For more information on this trial, please contact [email protected] or visit the clinical trials posting.