ATG/GCSF

TrialNet ATG-GCSF New Onset Study

Dear TrialNet Family,

As we announce the year one findings for the ATG-GCSF New Onset Study, I’d like to take a moment to give a big and well-deserved thank you to everyone who made this study possible:

  • The families who participated—for being the focus and essential element in everything we do at TrialNet. 
  • The TrialNet nurses and healthcare providers-- for upholding the highest research standards and taking such good care of participating families.
  • Our fellow diabetes researchers around the globe-- study by study, volunteer by volunteer, we are unraveling and conquering type 1 diabetes.
  • Everyone at the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the American Diabetes Association and JDRF-- for your continued support. We also thank Congress for funding the Special Diabetes Program, an important program that provides critical funding for NIH T1D research.
  • The Helmsley Charitable Trust for providing funding.
  • Sanofi for providing ATG and funding.
  • Amgen for providing GCSF.

Here we share with you our year one primary findings. We’ll be back with final study findings in early 2019.

Until then,

Carla Greenbaum, M.D.
TrialNet Chair
Diabetes Clinical Research Program Director, Benaroya Research Institute at Virginia Mason
Eligibility 
Participants in Stage 3
Type 
Newly Diagnosed
Status 
Completed - Year 1

About the Study

Study Details

This study was designed to build on prior findings of a pilot study suggesting thymoglobulin (ATG) combined with pegylated granulocyte colony stimulating factor (GCSF) preserved insulin production for more than 1 year after treatment in people who had type 1 diabetes for 4 months to 2 years.

TrialNet researchers wanted to know if ATG alone or in combination with GCSF could slow insulin loss when started earlier. To find out, we enrolled 89 people between age 12 and 45 diagnosed with type 1 diabetes within the past 100 days.

Participants were divided into three groups: one group received ATG, one group received ATG combined with GCSF, and one group received a placebo (looks like the study drug but is inactive). Everyone is participating in the study for two years.

Study Results

Key Findings

ATG-GCSF New Onset Study year one primary findings (one year after start of treatment) were presented at the 2018 ADA Scientific Sessions on June 25, 2018. Now, we share them with you.

  • Low-dose ATG preserved beta cell function and improved insulin production.
  • Low-dose ATG combined with GCSF did not enhance beta cell preservation.
  • Hemoglobin A1c levels (an indicator of long-term blood sugar control) were significantly reduced in people treated with low-dose ATG alone and in those treated with low-dose ATG combined with GCSF, as compared to placebo.

What's Next

Next Steps

  • All participants will complete their 2-year study visits by August 2018.
  • Final findings will be reported in 2019.
  • TrialNet is considering future studies to learn whether ATG alone, or in combination with other drugs, will prevent or delay disease onset.

In addition, TrialNet is continually planning and launching new studies. Also, we always encourage family members of people with T1D to get screened through the Pathway to Prevention study.

Participant Experience

For Study Participants

Thank you to our amazing participants who made this research possible. 
  • It is important for you to continue to attend all scheduled study visits.
  • Everyone will reach the 2-year study final endpoint by August 2018.
  • After you’ve completed all study visits, you will be invited to join the LIFT Study (Long-Term Investigative Follow-Up in TrialNet). This study gives participants personal ongoing monitoring by experts at the forefront of T1D research.
  • Final findings will be reported in 2019. You will get instructions by mail and/or email on how to access overall study results via a secure TrialNet website, as well as by phone.
  • Soon after final 2-year findings are released, we will contact you to set up a time to discuss your individual results and next steps.
  • Again, thank you for your continued participation in this important study.

If you have questions about study results, please contact your study team or info@trialnet.org

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