CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1
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|ClinicalTrials.gov Identifier: NCT01773707|
Recruitment Status : Recruiting
First Posted : January 23, 2013
Last Update Posted : May 14, 2019
The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial.
All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM.
The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM.
Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Abnormal Glucose Tolerance Type 1 Diabetes||Drug: CTLA4-Ig (Abatacept) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1 Diabetes|
|Actual Study Start Date :||March 2013|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: abatacept IV infusion
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)
Drug: CTLA4-Ig (Abatacept)
Given as 30 minute IV infusion
Other Name: Abatacept
Placebo Comparator: Placebo
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.
Saline given as 30 minute IV infusion
- Change from Normal Glucose Tolerance to Abnormal Glucose Tolerance [ Time Frame: every six months for 5-6 years ]
Measured by Oral Glucose Tolerance Test (OGTT):
Abnormal Glucose Tolerance is primary endpoint and defined as:
- Fasting plasma glucose ≥ 110 mg/dL (6.1 mmol/L) and < 126 mg/dL (7 mmol/L), or
- 2 hour plasma glucose ≥ 140 mg/dL (7.8 mmol/L) and < 200 (11.1 mmol/L), or
- 30, 60, 90 minute plasma glucose during OGTT ≥ 200 mg/dL (11.1 mmol/L)
- Change in C-peptide response to Oral Glucose Tolerance Test (OGTT) [ Time Frame: Every six months for 5-6 years ]To Determine whether treatment with Abatacept is superior to placebo with respect to C-peptide response to oral glucose tolerance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773707
|Contact: Lisa E Rafkin, MSemail@example.com|
|Contact: Ryan O'Donnell, MSfirstname.lastname@example.org|
|Study Chair:||Carla J Greenbaum, MD||Type 1 Diabetes TrialNet|