Testing Concentrated Insulin in a Custom-built Insulet OmniPod Pump
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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