New Biosimilar Insulin May Provide Cheaper Alternative to Lantus — How Does it Compare?

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: NCT02302716

Trial name: A Study of LY2963016 Compared to Lantus in Adult Participants with Type 2 Diabetes Mellitus (Element 5)

Diabetes type: Type 2 diabetes

What it’s testing: This trial is evaluating the safety and efficacy of the insulin “LY2963016” compared to Lantus in adults with type 2 diabetes who are on two or more oral anti-diabetic medications (diabetes pills, e.g., metformin, SGLT-2 inhibitors, DPP-4 inhibitors). LY2963016 is Lilly/BI’s version of insulin glargine, a long-acting/basal insulin for type 1 and type 2 diabetes.

Trial participants will be randomly selected to receive daily injections of either LY2963016 or Lantus for 24 weeks while continuing to take their current doses of oral anti-diabetic medications.

What the trial is measuring: Change in A1c over 24 weeks, changes in basal insulin dose, changes in body weight, and others. More details here.

Why is this new/important: Sanofi’s patent for Lantus expires this year, leaving the door open for other companies to introduce “biosimilar” versions of insulin glargine – in the case of Lilly/BI’s LY2963016 (and others in development), it has the same protein sequence and comparable blood sugar-lowering effects. This insulin already received “tentative approval” from the FDA back in August 2014, with full approval possibly delayed until the fall of 2016 pending the outcome of a lawsuit. This study appears to be an attempt to collect additional data to show the effectiveness of LY2963016 specifically in those taking oral diabetes drugs.

LY2963016 is already approved in Europe as Abasaglar (currently available in Czech Republic, Estonia, and Slovakia, and the UK) and would be branded as Basaglar in the US. Biosimilar insulins may be priced cheaper than branded products like Lantus, though the discounts will almost certainly not be as steep as those for generic vs. brand-name pills. 

Trial Length: 24 weeks

Trial Location: The trial is located in 9 US states (FL, GA, KS, NY, OH, TN, TX, UT, WA) as well as India, Republic of Korea, Puerto Rico, Russian Federation, Taiwan, and Turkey.

Do you qualify? To qualify, one must:

• Be 18 years or older

• Have type 2 diabetes

• Currently be taking two or more oral anti-diabetic medications

• Have an A1c of less than 7%

• Have a BMI of less than 45

Individuals who answer “yes” to any of the following questions are not eligible for this study:

• Have you taken Lantus more than once daily within the previous 30 days?

• Have you been exposed to a biosimilar insulin glargine (such as Abasaglar) within the previous 90 days?

• Have you taken basal plus mealtime insulin (basal bolus therapy) within the last year for greater than four continuous weeks?

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