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Monoclonal Antibodies

Siplizumab for Type 1 Diabetes (DESIGNATE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 8 to 45 years of age
Positive for at least one diabetes-related autoantibody: Glutamate decarboxylase (GAD-65), Insulin (if obtained within 10 days of the onset of exogenous insulin therapy), Insulinoma antigen-2 (IA-2), or Zinc transporter-8 (ZnT8)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 6, 12, 24, 36 and 52.
Awards & highlights

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.

Who is the study for?
This trial is for individuals aged 8-45 with Type 1 diabetes diagnosed within the last 18 months. They must have completed their primary COVID-19 vaccination series, not be on certain diabetes or immunosuppressive medications, and cannot have a history of severe reactions to monoclonal antibodies or significant cardiovascular disease.Check my eligibility
What is being tested?
The study tests different doses of Siplizumab in patients with Type 1 diabetes. Participants will receive weekly doses for 12 weeks and then be monitored up to one year. The goal is to find a safe dose that affects T cell behavior similar to another therapy (alefacept) and preserves insulin-producing cells.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include those common to humanized monoclonal antibody treatments such as allergic reactions, immune system changes, and infusion-related responses.

DESIGNATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 45 years old.
Select...
I have diabetes and tested positive for a diabetes-related autoantibody.

DESIGNATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 6, 12, 24, 36 and 52.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 6, 12, 24, 36 and 52. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Triethylenemelamine
T-Lymphocyte
Acceptable T cell phenotype signature by the change from baseline in the Programmed Cell Death 1 (PD1) during first 12 weeks.
+1 more
Secondary outcome measures
Frequency of Adverse Event (AEs) in all siplizumab dosing arms
Insulin use (U/kg/day)
Mixed Meal Tolerance Test (MMTT)-stimulated mean 2-hour C-peptide AUC

Side effects data

From 2020 Phase 1 trial • 15 Patients • NCT01445535
100%
Albumin, serum-low (hypoalbuminemia)
100%
Febrile neutropenia
100%
Hemoglobin
100%
Lymphopenia
100%
Neuropathy: sensory
100%
Neutrophils/granulocytes (ANC/AGC)
100%
Leukocytes (total WBC)
100%
Platelets
67%
Mucositis/stomatitis (clinical exam)::Oral cavity
67%
Phosphate, serum-low (hypophosphatemia)
67%
Rash/desquamation
67%
CD4 count
67%
Hypotension
67%
Hypoxia
67%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
67%
Diarrhea
67%
Nausea
33%
ALT, SGPT (serum glutamic pyruvic transaminase)
33%
Fatigue (asthenia, lethargy, malaise)
33%
Heartburn/dyspepsia
33%
Hair loss/alopecia (scalp or body)
33%
Insomnia
33%
Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS
33%
Pain::Lymph node
33%
Constipation
33%
Dizziness
33%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
33%
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
33%
Pain::Back
33%
Vomiting
33%
Cardiac troponin I (cTnI)
33%
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
33%
Palpitations
33%
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
33%
Cough
33%
AST, SGOT(serum glutamic oxaloacetic transaminase)
33%
Hemorrhage, pulmonary/upper respiratory::Nose
33%
Infection (documented clinically or microbiologically)
33%
Pain::Middle ear
33%
Pain::Oral cavity
33%
Calcium, serum-low (hypocalcemia)
33%
Potassium, serum-low (hypokalemia)
33%
Sodium, serum-low (hyponatremia)
33%
Pain::Pain NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3 - 8.5 mg/kg
Cohort 4 - 15 mg/kg
Cohort 1 - 3.4 mg/kg
Cohort 2 - 4.8 mg/kg

DESIGNATE Trial Design

8Treatment groups
Experimental Treatment
Group I: Children with T1D 0.22 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks
Group II: Children with T1D 0.18 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 3: 0.18 mg/kg SQ dose for a total of 12 weeks
Group III: Children with T1D 0.12 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 2:0.12 mg/kg SQ dose for a total of 12 weeks
Group IV: Children with T1D 0.08 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 2 Group 1:0.08 mg/kg SQ dose for a total of 12 weeks
Group V: Adults with T1D 0.22 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group 4: 0.22 mg/kg SQ dose for a total of 12 weeks
Group VI: Adults with T1D 0.18 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group 3:0.18 mg/kg SQ dose for a total of 12 weeks
Group VII: Adults with T1D 0.12 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group 2: 0.12 mg/kg SQ dose for a total of 12 weeks
Group VIII: Adults with T1D 0.08 mg/kg SQ doseExperimental Treatment1 Intervention
Cohort 1 Group1: 0.08 mg/kg SQ dose for a total of 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siplizumab
2009
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,012 Total Patients Enrolled
Stephen Gitelman, M.D.Study ChairUniversity of California San Francisco, School of Medicine: Diabetes Center

Media Library

Siplizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05574335 — Phase 1 & 2
Type 1 Diabetes Research Study Groups: Children with T1D 0.12 mg/kg SQ dose, Children with T1D 0.18 mg/kg SQ dose, Children with T1D 0.22 mg/kg SQ dose, Adults with T1D 0.08 mg/kg SQ dose, Adults with T1D 0.12 mg/kg SQ dose, Adults with T1D 0.18 mg/kg SQ dose, Adults with T1D 0.22 mg/kg SQ dose, Children with T1D 0.08 mg/kg SQ dose
Type 1 Diabetes Clinical Trial 2023: Siplizumab Highlights & Side Effects. Trial Name: NCT05574335 — Phase 1 & 2
Siplizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05574335 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
What site did they apply to?
Stanford School of Medicine: Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes
University of Miami Miller School of Medicine: Diabetes Research Institute
Indiana University Medical Center: Riley Hospital for Children, Department of Pediatric Endocrinology & Diabetology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Columbia University Medical Center: Naomi Berrie Diabetes Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Siplizumab in T1DM
2023. "Siplizumab in T1DM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05574335.
All > Toronto
~80 spots leftby Dec 2026
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