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Immunomodulator

CTLA4-Ig (Abatacept) for Type 1 Diabetes

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 months

Summary

This trial is testing whether Abatacept can prevent or delay abnormal blood sugar levels and type 1 diabetes in high-risk individuals. Participants are relatives of type 1 diabetes patients who have certain antibodies but normal blood sugar levels. Abatacept works by stopping the immune system from attacking insulin-producing cells.

Eligible Conditions

Type 1 Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time From Randomization to Confirmed Abnormal Glucose Tolerance Test

Secondary study objectives

Change in C-peptide Concentration to Oral Glucose Tolerance Test (OGTT)

Side effects data

From 2022 Phase 2 trial • 212 Patients • NCT01773707

38%

Infections and infestations

22%

Gastrointestinal Disorders

19%

Musculoskeletal and Connective Tissue

17%

Skin and subcutaneous tissue disorders

16%

Respiratory, thoracic and mediastinal disorders

15%

Injury, poisoning and procedural

14%

General disorders and administration site

13%

Nervous system disorders

Surgical and medical procedures

Psychiatric disorders

Metabolism and nutrition disorders

Eye disorders

Neoplasms benign, malignant and unspecified

Investigations

Cardiac disorders

Blood and lymphatic system disorders

Reproductive system and breast disorders

Endocrine disorders

Renal and urinary disorders

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Vascular disorders

Pregnancy, puerperium and perinatal

Immune system disorders

Ear and labyrinth disorders

Hepatobiliary disorders

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept IV Infusion

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: abatacept IV infusionExperimental Treatment1 Intervention

CTLA4-Ig (Abatacept) will be administered as 14 (30 minute) infusions over one year (3 infusions every other week the first month; monthly for the following 11 months)

Group II: PlaceboPlacebo Group1 Intervention

The placebo arm will receive 14 (30 minute) IV infusions (containing saline) given 3 times (every other week) the first month and monthly for the following 11 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CTLA4-Ig (Abatacept)

2013

Completed Phase 2

~220

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