Could an Innovative Mealtime Insulin Help You?
By Arvind Sommi
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A clinical trial by Lilly is seeing if your Time in Range could improve from taking Lyumjev, a ultra-rapid mealtime insulin, along with long acting insulin glargine.
Clinical Trials Identifier: NCT04605991
Trial Name: A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Diabetes Type: Adults with type 2 diabetes on insulin
Trial Sponsor: Eli Lilly and Company
What is the trial testing?
The study is looking to enroll 167 participants to evaluate their glucose levels while taking Lilly’s Lyumjev (called LY900014) ultra-rapid acting mealtime insulin along with long-acting insulin glargine. As part of the study, participants will use the Freestyle Libre 14-day continuous glucose monitoring (CGM) system throughout the study to track their glucose values.
Researchers will primarily be measuring participants’ change in their Time in Range (TIR) from the start of the trial to 12 weeks (glucose values between 70 to 180 mg/dL). The researchers will also be measuring their change in A1C over this time period, as well as other metrics such as Time Below Range and Above Range, changes in insulin dosages, and the participants’ satisfaction.
Why is this new and important?
Ultra-rapid acting mealtime insulins are designed to help prevent the post-meal spikes in glucose that can often occur. These newer insulins, like Lyumjev, can also have the ability to give people with diabetes slightly more freedom in when they deliver their insulin dose prior to eating as well (for example, Lyumjev can be taken at the beginning of a meal or 20 minutes after starting it – though it is still strongly recommended that whenever possible, people should take Lyumjev before the start of the meal).
The PRONTO-Time in Range trial is building off of results from the PRONTO-T1D and PRONTO-T2D trials which helped pave the way for the FDA approval of Lyumjev. This trial is looking specifically at the effects that this insulin can have on TIR (as opposed to just A1C and individual glucose readings).
By volunteering to be in this clinical trial, you will be provided with a Freestyle Libre CGM system for the duration of the study. We are also excited to see that Time in Range is the primary outcome measurement in this clinical trial. The diaTribe Foundation advocates for greater adoption of Time in Range as a clinically meaningful endpoint to improve the lives of people with diabetes. To learn more about Time in Range and why it is important, check out diaTribe’s Time in Range resource page.
Trial Length: 12 weeks
Trial Locations: This is a multicenter study with 30 locations across the United States and 2 locations in Puerto Rico. You can see a list of all participating locations here.
Are you interested?
You may be eligible to participate in this study if you are:
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Have had type 2 diabetes for at least 1 year prior to screening
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Have an A1C between 7.5% and 10%
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Currently on multiple daily injection (MDI) therapy and have been for at least 90 days prior to screening
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Currently on a stable dose of oral glucose lowering medication or an injectable GLP-1 receptor agonists for at least 90 days prior to screening (can be on up to three)
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Have not had an incident of severe hypoglycemia or diabetic ketoacidosis in the last six months
You can see a full list of eligibility and exclusion criteria here.
For More Information: To learn more, please contact the Eli Lilly study team at 1-877-CTLILLY (1-877-285-4559) or Clinicaltrials.gov@lilly.com
