Your session is about to expire
← Back to Search
Immunomodulator
CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1
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
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 • NCT0177370738%
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
9%
Surgical and medical procedures
7%
Psychiatric disorders
5%
Metabolism and nutrition disorders
5%
Eye disorders
4%
Neoplasms benign, malignant and unspecified
3%
Investigations
3%
Cardiac disorders
3%
Blood and lymphatic system disorders
3%
Reproductive system and breast disorders
3%
Endocrine disorders
3%
Renal and urinary disorders
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Vascular disorders
2%
Pregnancy, puerperium and perinatal
2%
Immune system disorders
2%
Ear and labyrinth disorders
2%
Hepatobiliary disorders
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,455 Previous Clinical Trials
4,334,896 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
235 Previous Clinical Trials
142,229 Total Patients Enrolled
Carla J Greenbaum, MDStudy ChairType 1 Diabetes TrialNet
1 Previous Clinical Trials
76 Total Patients Enrolled