NCT00505375

Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

Effects of CTLA-4 Ig (Abatacept) On The Progression of Type 1 Diabetes In New Onset Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 6 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.

Detailed description

Type 1 diabetes mellitus (T1DM) is a T-cell mediated autoimmune disease in which insulin-producing beta cells are completely or near completely destroyed resulting in life-long dependence on exogenous insulin. CTLA4-Ig (Abatacept) inhibits a crucial stimulatory pathway in the activation of T cells. By this mechanism, the drug is thought to arrest or slow the T cell mediated autoimmune destruction of beta-cells and preserve their function. At the time of clinical onset of T1DM, a significant amount of insulin producing beta cells are destroyed, but as many as 10-20% are still capable of insulin production. By using CTLA4-Ig close to the onset of T1DM, we hope to arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous insulin production. CTLA4-Ig regulates T cell function but does not deplete T cells. Therefore, its safety profile appears to be better than other immunosuppressive agents. Eligible participants will be randomized to the experimental or control groups. The experimental group will receive intravenous infusions of CTLA-4 Ig. The first infusion will occur at the time of randomization, followed by another infusion 2 and 4 weeks later. Subsequent infusions will be given monthly for two years during the treatment phase of the study. There is a total of 27 infusions during the treatment phase of the study. Participants in the control group will receive intravenous infusions of placebo according to the same schedule outlined above. Both groups will receive standard intensive diabetes treatment with insulin and dietary management. All participants randomized into the study will be seen at study site monthly for 24 months and then every 6 months for up to an additional 2 years. Participants will undergo assessments of their insulin production, immunologic status, overall health and well being and diabetes care.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	CTLA-4 Ig	Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
OTHER	Placebo	Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2007-07-23
• Last updated: 2020-05-06
• Results posted: 2016-08-16

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study