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Siplizumab for Type 1 Diabetes (DESIGNATE Trial)
DESIGNATE Trial Summary
This trial assesses the safety and efficacy of siplizumab in people (8-45 yrs) newly diagnosed w/ Type 1 Diabetes Mellitus (T1DM) over 12 wks, to identify a dosing regimen that induces changes in T cell phenotypes. It also assesses safety profile & effects on residual beta cell function.
DESIGNATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDESIGNATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 trial • 15 Patients • NCT01445535DESIGNATE Trial Design
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Who is running the clinical trial?
Media Library
- I am not pregnant, breastfeeding, nor planning to become pregnant during the study.You have had a serious allergic reaction to milk or soy proteins in the past.I have a history of serious heart problems.I was diagnosed with Type 1 Diabetes less than 18 months ago.I have been diagnosed with cancer before or have it now.I have used treatments that could affect my type 1 diabetes or immune system.I am a woman able to have children and agree to use birth control from 2 weeks before the study starts until Week 52.I have not received any live vaccines in the last 30 days.I have diabetes-related antibodies such as GAD-65, Insulin, IA-2, or ZnT8.I have not had any serious infections or HIV, hepatitis B or C, TB, EBV, CMV, or COVID-19 recently.I have completed all recommended COVID-19 vaccinations.Your recent blood tests show abnormal levels of white blood cells, platelets, hemoglobin, liver enzymes, or creatinine.I haven't taken any medication that affects blood sugar levels in the last 14 days.I have used diabetes medication in the last 30 days.I have no autoimmune diseases except stable thyroid or celiac disease.You have a mental illness or problems with drug or alcohol use that could make it hard for you to follow the study's rules.I have had a bone marrow transplant or an autoimmune disease that affects my white blood cells.I haven't taken any experimental drugs in the last 24 weeks, except for COVID-19 vaccines or treatments.You have had a severe reaction or anaphylaxis to humanized monoclonal antibodies in the past.I am between 8 and 45 years old.My C-peptide level was above 0.15 pmol/mL after a test, done 3 weeks after diagnosis and within 37 days of joining the study.I have diabetes and tested positive for a diabetes-related autoantibody.
- Group 1: Children with T1D 0.12 mg/kg SQ dose
- Group 2: Children with T1D 0.18 mg/kg SQ dose
- Group 3: Children with T1D 0.22 mg/kg SQ dose
- Group 4: Adults with T1D 0.08 mg/kg SQ dose
- Group 5: Adults with T1D 0.12 mg/kg SQ dose
- Group 6: Adults with T1D 0.18 mg/kg SQ dose
- Group 7: Adults with T1D 0.22 mg/kg SQ dose
- Group 8: Children with T1D 0.08 mg/kg SQ dose
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you tell me if the age limit for participants in this research is 30 years old?
"This trial's age requirements for participants are between 8 and 45 years old."
Is this study actively looking for participants right now?
"No, according to the latest data from clinicaltrials.gov, this particular trial is not recruiting patients at this time. The trial was first posted on November 24th, 2022 and last updated on October 6th, 2022. There are plenty of other trials currently underway that may be seeking participants."
Is this clinical trial exclusive to North American hospitals?
"There are 20 different enrolling locations for this clinical trial, but a few notable ones include University of Alabama at Birmingham: Division of Endocrinology, Diabetes and Metabolism in Birmingham, Alabama, University of Colorado School of Medicine: Barbara Davis Center for Diabetes in Aurora, Colorado, and Joslin Diabetes Center: Joslin Clinic in Boston, Massachusetts."
Are there any restrictions on who can take part in this experiment?
"This clinical trial is only for type 1 diabetes mellitus patients aged 8 to 45. Out of the total 120 participants, how many will be chosen remains to be seen."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Columbia University Medical Center: Naomi Berrie Diabetes Center: < 48 hours
Average response time
- < 2 Days
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