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Immunosuppressant

Low-Dose ATG for Type 1 Diabetes (TN28 Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 12 and < 35 years

ADA Stage 2 criteria* AND at least one of the following high-risk markers (occurring at the same visit) within 7 weeks (52 days) of randomization, defined below (for defining a 2-year 50% risk for progression to Stage 3 T1D): a. HbA1c ≥ 5.7 and <6.5% b. Index60 ≥ 1.4 i. Index60 = 0.3695 × (log fasting C-peptide [ng/mL]) + 0.0165 × 60-min glucose (mg/dL) - 0.3644 × 60-min C-peptide (ng/mL) c. DPTRS ≥ 7.4 DPTRS = (1.57 x log BMI) - (0.06 x age) + (0.81 x glucose sum from 30 to 120 min/100) - (0.85 x C-peptide sum from 30 to 120 min/10) + (0.48 x log fasting C-peptide)

Must not have

Hemoglobin less than 13.5 g/dL for adult men and less than 12 g/dL for adult females and less than 11 g/dL for participants under age 18

A history of malignancies other than of skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Summary

This trialtests if a drug can help prevent Type 1 diabetes from getting worse in people at risk.

Who is the study for?

This trial is for people aged 12-35 with a high risk of developing stage 3 Type 1 Diabetes, as indicated by specific blood markers. They must be healthy, not pregnant, willing to avoid live vaccines and comply with COVID-19 safety measures. Participants cannot have certain infections or immune conditions.

What is being tested?

The study tests if low-dose Antithymocyte Globulin (ATG) can prevent progression to stage 3 Type 1 Diabetes compared to a placebo. It's double-blind and participants are randomly assigned in a ratio of two ATG recipients for every one placebo recipient.

What are the potential side effects?

Potential side effects include allergic reactions to the medication, which is derived from rabbits. There may also be risks associated with immunosuppression such as increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 34 years old.

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I meet the criteria for early-stage diabetes and have high-risk markers.

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I meet the criteria for early-stage diabetes and have high-risk markers.

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My BMI is within the healthy range for my age.

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I am fully vaccinated against COVID-19, including boosters, and tested negative recently.

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My blood pressure is below 130/80 mmHg if I'm 18 or older, or below the 95th percentile for my age, sex, and height if I'm younger.

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I live or can stay close to the treatment center and a hospital for 3 days during my treatment.

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My weight is above the 5th percentile for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hemoglobin levels are below the normal range for my age and gender.

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I have had cancer other than skin cancer in the past.

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I am using non-insulin diabetes medication.

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I am currently using immunosuppressive drugs or steroids regularly.

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My kidney function is not normal, as shown by my creatinine levels.

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I do not have symptoms of an active infection, including COVID-19.

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I have a weak immune system or low blood cell counts.

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I have previously been treated with Teplizumab.

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I was diagnosed with Stage 3 Type 1 Diabetes.

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I have been treated with ATG or am allergic to rabbit products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression to Stage 3 T1D

Side effects data

From 2016 Phase 2 trial • 52 Patients • NCT00385788

92%

Nausea

75%

Bilirubin

67%

Transaminitis

67%

Mucositis

50%

Pulmonary

50%

Neurologic Pain

42%

Cardiac

33%

Creatinine

33%

Diarrhea

25%

Fever

25%

Acute Renal Failure

25%

Fatigue

17%

Acute Respiratory Failure

17%

Skin Rash

17%

BK Cystitis

Cardiac Dysfunction

Gastrointestional (GI) Bleed

Seizure/Encephalopathy

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Fludarabine + Melphalan

Gemcitabine + Fludarabine + Melphalan

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Antithymocyte globulin (ATG)Experimental Treatment1 Intervention

Antithymocyte globulin (ATG) will be intravenously administered over two days, with a total of 2 infusion periods. The first infusion is given at baseline visit (day 1), the second is given the next day at baseline visit (day 2). Body weight at baseline (Day 0- admission for the ATG/placebo infusion) will be used in calculating the doses for all infusions. The first dose (0.5mg/kg) will be infused over a minimum of 4 hours, and the second dose (2mg/kg) over a minimum of 4 hours with a maximum infusion time for each infusion of 10 hours. The second dose should be given no less than 12 and no more than 30 hours from the start of the first infusion. The final prepared product is to be labeled to protect the blind. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.

Group II: PlaceboPlacebo Group1 Intervention

0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. The placebo is to be prepared dispensing an infusion bag of 0.9% Sodium Chloride Injection USP ("Normal" saline) with no additives (no ATG, no premedications) and label the product to protect the blind. The placebo will also be administered over a minimum of 4 hours for the first and second doses with a maximum infusion time of 10 hours. The second dose of the placebo arm should be given no less than 12 and no more than 30 hours from the start of the first infusion. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antithymocyte Globulin

2000

Completed Phase 3

~180

0 / 18Eligibility criteria met