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GAD65 Antigen Therapy inRecently Diagnosed Type 1

Diabetes Mellitus Raihana Saktiriyani

110.2006.212

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Background

The clinical onset of type 1 diabetesis manifested by the effects ofinadequate insulin secretion due to the immunologic destruction ofpancreatic-islet beta cell

The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a majorautoantigen in type 1 diabetes.

hypothesized that alum-formulated GAD65 (GAD-alum) can preservebeta-cell function in patients with recent-onset type 1 diabetes.

Abstract

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Studied in 334 patients, 10 to 20 years ofage, with type 1 diabetes, fasting C-

peptide levels of more than 0.3 ng permilliliter (0.1 nmol per liter), and

detectable serum GAD65 autoantibodies.Within 3 months after diagnosis

Methods

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I : four doses of

GAD-alum

II : two doses ofGAD-alum

followed by twodoses of placebo

III : four doses ofplacebo.

Study Treatments and Procedures

subcutaneous injections of 20 g of GAD-alum on days 1, 30, 90,

and 270

patients were randomly assigned to receive one of three study treatments:

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The pri-mary outcomewas the change in thestimulated serum C-

peptide level (after amixed-meal tolerancetest) between thebaseline visit and the 15-month visit.

Secondary outcomesincluded the glycatedhemoglobin level, meandaily insulin dose, rateof hypoglycemia, andfasting and maximum

stimulated C-peptidelevels.

Outcome

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Medical assessments were performed onday 1 and at months 1, 3, 9 and 15 of thestudy.GAD65 autoantibody levels and insulin-doseinformation for the 4 days before each visitwere collected.

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We estimated that 93 patients in each of the threestudy groups would provide 90% power to detect a45% difference in the primary end point be-tween

each of the two GAD-alum groups and the placebogroup at a two-sided significance level of 5%.

Statistical Analysis

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The stimulated C-peptidelevel declined to a similar

degree in all studygroups, and the primary

outcome at 15 months did

not differ significantlybetween the com-binedactive-drug groups and

the placebo group

Results

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Treatment with GAD-alum did notsignificantly reduce the loss of

stimulated C pep-tide or improve clinical

outcomes over a 15-month period.

Conclusions

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