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Testing Concentrated Insulin in a Custom-built Insulet OmniPod Pump

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: NCT02561078

Trial Name: An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus (VIVID)

Diabetes Type: Type 2 Diabetes

What it's testing: This trial will assess the efficacy and safety of taking concentrated insulin (U-500) in an insulin pump vs. multiple daily injections (MDI).

What the trial is measuring: Change in A1c, as well as other glucose outcomes such as change in fasting glucose and rates of hypoglycemia. 

Why is this new/important: Many people with type 2 diabetes need U-500 concentrated insulin (instead of the standard U-100), which is notoriously difficult and confusing to take (lots of multiplication!). Insulet, who makes the tubeless OmniPod patch pump, has been working with Lilly to develop a custom system for use with U-500 insulin. This trial will test the new system and could pave the way for FDA approval. We hope it will make use of U-500 insulin easier and much safer.

Trial Length: 26 weeks

Trial Location: The trial is currently recruiting in the following US states and Puerto Rico: AL, CA, FL, ID, IL, IA, KS, KY, LA, MI, MO, MT, NE, NV, NH, NY, NC, OK, OR, PA, RI, TN, TX, WA. For a full list of current and future locations, see here.

Do you qualify?

  • 18 to 85 years old

  • Type 2 diabetes

  • A1c between 7.5% and 12.0%

  • History of stable body weight

  • BMI greater than 25 but under 50

Exclusion criteria include:

  • Diagnosed with type 1 diabetes

  • Have history of more than one episode of severe hypoglycemia within six months prior to screening

  • Have used any weight loss drugs in the three months prior to screening or have a history of bariatric surgery

  • Have received U-500R insulin by pump in the three months prior to screening

  • Have chronic kidney disease Stage 4 and higher or history of renal transplantation

  • Have liver disease

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. –JB/AB

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