| Outcome Measures: |
Primary: Adverse events possibly or probably related to GABA treatment, To evaluate the acute and long-term safety of oral GABA treatment. The endpoint will investigate number of adverse events possibly or probably related to GABA treatment., 6 months | Secondary: Difference in C-peptide response to mixed meal tolerance test before and directly after treatment, Difference in C-peptide (Area under the curve 0-120 min) during a mixed meal tolerance test between baseline and after 6 months of oral GABA treatment, 6 months|Difference in C-peptide response to mixed meal tolerance test during and after treatment, Difference in C-peptide (Area under the curve 0-120 min) during a mixed meal tolerance test between baseline and after 3 and and 6 months of treatment and between baseline and the follow-up visit, 7 months|Difference in maximum stimulated C-peptide to mixed meal tolerance test during and after treatment, Difference in maximum stimulated C-peptide during a mixed meal tolerance test between baseline and after 3 and 6 months of treatment and between baseline and the follow-up visit., 7 months|Difference in C-peptide response to mixed meal tolerance test during and after treatment between treatment groups, Difference in C-peptide (Area under the curve 0-120 min) during a mixed meal tolerance test between treatment group 1 and 2 and after 3 and 6 months of treatment and between baseline and the follow-up visit, 7 months|Difference in glucagon response during a hypoglycemic clamp before and after treatment, Difference in glucagon (area under the curve) during a hypoglycemic clamp between baseline and 6 months of treatment, 7 months|Difference in glucagon response during a hypoglycemic clamp between treatment groups before and after treatment, Difference in glucagon (area under the curve) during a hypoglycemic clamp between treatment group 1 and 2 between baseline and 6 months of treatment, 7 months|Change in HbA1c by treatment, Change in HbA1c between 0,3 and 6 months of treatment and at the follow-up one month later., 7 months|Change in exogenous insulin consumption by treatment, Change in exogenous insulin consumption between 0,3 and 6 months of treatment and at the follow-up one month later., 7 months|Change in fasting C-peptide by treatment, Change in fasting C-peptide levels between 0,3 and 6 months of treatment and at the follow-up one month later., 7 months|Change in variables that indicate effects on immune system, Change by treatment in variables that indicate effects on the immune system such as serum autoantibodies to GAD65 and islet antigen-2, and immune cells, 7 months|Change in GABA plasma levels, Analysis of GABA plasma levels after 0, 3 and 6 months of treatment and at the follow-up visit one month later., 7 months|Change in diabetes treatment satisfaction questionnaire, Measurements of patient diabetes treatment satisfaction by questionnaire during study. Each of eight questions have a 7-graded scale from 0-6. 48 points are therefore maximal treatment satisfaction and comparisons will be made to score before treatment start., 7 months
|
