Diamyd® significantly reduces insulin dependence! Only 14% in the 20 µg subgroup needed insulin, compared to 64% in the placebo subgroup!!
DIAMYD® PREVENTS INSULIN TREATMENT
"We saw a steep improvement in beta cell function already at six months after vaccination in patients treated with 20 µg of Diamyd®", says Professor Agardh. "This improvement was largely maintained over the five years of the study."
diamyd.com
GAD65 vaccination significantly reduces insulin dependence at five years follow-up in a dose escalating study in adult-onset autoimmune diabetes patients
placebo 64%;
4 µg 71%;
20 µg 14%;
100 µg 14%;
500 µg 63%;
p=0.046).
.Of the remaining 40 patients followed for five years, dose level was significantly associated with number of patients starting insulin treatment (placebo 7/11 (64%); 4 µg group 5/7(71%); 20 µg 1/7 (14%); 100 µg 1/7(14%); 500 µg 5/8 (63%); p=0.046). Fasting C-peptide levels had declined significantly in the placebo (mean decline = 0.18; 95%CI = 0.02 - 0.34 nmol/L; p= 0.03) and 500 µg group (mean decline = 0.33; 95%CI = 0.07 - 0.57 nmol/L; p= 0.02), but no change was observed in the 4, 20 and 100 µg dose groups. Compared to placebo, fasting C-peptide had increased significantly only in the 20 µg dose group (0.34; 0.09 - 0.60 nmol/L, p=0.01). Of the patients who had not started insulin treatment, mean change in HbA1c was observed (although not statistically significantly) in the placebo (n = 4, 0.7 percentage), 4 µg (n=2, 1.8 percentage), 100 µg (n= 6, 1.3 percentage) and 500 µg (n=2, 1.0 percentage) dose group but not in the 20 µg dose group (n=6, -0.0).
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