TrialNet Studies      
Study Title and Selected Results Estimated  Enrollment 

Dates of Trial 

Selected Publications 

Effects of Oral Insulin in Relatives of Individuals with T1D in the Diabetes Prevention Trial-Type–1

Oral insulin did not delay or prevent T1D. In hypothesis-generating subgroup analysis with insulin autoantibody levels ≥ 80 nU/ml there was suggestion of benefit.

Target: 372

Final: 372

1994

2003

Skyler et al. Diabetes Care, 2005.

Vehik et al. Diabetes Care, 2011.

Improving Metabolic Assessments in T1D Clinical Trials - Comparison of the Reliability of Mixed Meal Tolerance Test and Glucagon Stimulation Test

MMTT is preferred for the assessment of beta-cell function in therapeutic trials in type 1 diabetes.

Target: 120

Final: 148

2004

2005

Greenbaum et al. Diabetes Care, 2008.

Comparative Study Between the Cytokine, ELIspot, Tetramer, Immunoblot and T Cell Proliferation Assays Using Fresh Blood Samples from Subjects with Recent Onset T1D

Target: 60-100

Final: 96

2005

2007

Herold et al. Diabetes, 2009.

"Pathway to Prevention" Natural History Study of the Development of T1D

(Screening, Follow-Up of At-Risk)

Ongoing

To date Screening:  > 135,000

To date at risk: > 4,000

2004

Ongoing

Mahon et al. Pediatric Diabetes, 2009.

Sosenko et al. Diabetes Care, 2011.

Vehik et al. Diabetes Care, 2011.

Greenbaum et al. Diabetes, 2012.

Sosenko et al. Diabetes Care, 2013.

Sosenko et al. Diabetes Care, 2014.

Oral Insulin for Prevention of Diabetes in Relatives At Risk for T1D

Ongoing

2007

Expect Enrollment End 2015

Outcome Expected 2017

 
Anti-CD3 (Teplizumab) for Prevention of Diabetes in Relatives At Risk for T1D

Ongoing

2011

Ongoing

Expected Enrollment End 2016

 
Effects of CTLA-4 Ig (Abatacept) for the Prevention of Abnormal Glucose Tolerance in Relatives at Risk For T1D

Ongoing

Target: 206

2013

Expect Enrollment End 2017

 
Long-Term Investigative Follow-Up Trial (LIFT) Ongoing

2012

Ongoing

 

Nutritional Intervention to Prevent T1D - Pilot Trial

The pilot study found that those who received DHA supplements (infants or nursing mothers) had a 61-100 percent increase in DHA compared to the untreated group. Six months of DHA supplementation was not successful at reducing inflammatory cytokines in infants. However, there appeared to be some reduction in cytokine levels at 12 and 18 months.

Target: 90

Final: 123

2006

2012

TrialNet E-News, 2012.

Effects of CTLA-4 Ig (Abatacept) on the Progression of T1D in New Onset Subjects

C-peptide reduction delayed by 9.6 months, decrease in β-cell function was parallel to that with placebo after 6 months of abatacept treatment.

Target: 108

Final: 112

2008

2011

Orban et al. Lancet, 2011.

Orban et al. Diabetes Care, 2014.

Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of T1D in New Onset Subjects

Vaccination with GAD-alum did not alter the course of loss of insulin secretion in the first year in patients with recently diagnosed type 1 diabetes.

Target: 126

Final: 145

2008

2011

Wherrett et al. Lancet, 2011.
Effect of Metabolic Control at Onset of Diabetes on Progression of T1D

Target: 72

Final: 71

2009

2015

 

Effects of Canakinumab on the Progression of Type 1 Diabetes in New Onset Subjects

Canakinumab was safe but not effective.

Target: 66

Final: 69

2010

2013

Moran et al. Lancet, 2013.

Effects of Rituximab on the Progression of T1D in New Onset Subjects

Rate of decline of C-peptide was shifted by 8.2 months with rituximab treatment.

Target: 66

Final: 87

2006

2008

Pescovitz et al. NEJM, 2009.

Yu et al. Diabetes, 2011.

Pescovitz et al. Diabetes Care, 2014.

New Onset T1D - Mycophenolate Mofetil/Daclizumab Clinical Trial

C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo.

Target: 120

Final: 126

2004

2009

Gottlieb et al. Diabetes Care, 2010.

Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes Target: ~84 Expected Start 2014