Penyakit gula akibat kerusakan pankreas yang sering dialami sejak usia anak-anak merupakan penyakit autoimun. Upaya pencarian obat untuk penyakit gula ini senantiasa dilakukan, karena penderita penyakit ini bila organ pankresnya tidak membaik maka mereka membutuhkan insulin seumur hidupnya, tentu itu akan berhubungan dengan biaya, risiko ketidaknyamanan dalam cara pemberian insulin, reaksi penolakan atau adanya komplikasi. Baru-baru ini NEJM melaporkan hasil penelitian klinik obat baru bagi penderita baru DM tipe I yang berjudul” GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus” namun penelitian ini masih belum memberikan hasil sebagaimana yang diharapkan. Hasil selengkapnya abstrak laporan tersebut silakan baca pada kopian sbb:GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus

Johnny Ludvigsson, M.D., Ph.D., David Krisky, M.D., Ph.D., Rosaura Casas, Ph.D., Tadej Battelino, M.D., Ph.D., Luis Castaño, M.D., Ph.D., James Greening, M.D., Olga Kordonouri, M.D., Timo Otonkoski, M.D., Ph.D., Paolo Pozzilli, M.D., Jean-Jacques Robert, M.D., Ph.D., Henk J. Veeze, M.D., Ph.D., and Jerry Palmer, M.D.

N Engl J Med 2012; 366:433-442February 2, 2012

Abstract
Article
References
Background

The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes.

Full Text of Background…
Methods

We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels.

Full Text of Methods…
Results

The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences.

Full Text of Results…
Conclusions

Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period. (Funded by Diamyd Medical and the Swedish Child Diabetes Foundation; ClinicalTrials.gov number, NCT00723411.)