| Primary | Change in Stimulated C-peptide During a MMTT | Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve [AUC] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model. | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. 1 patient in the active arm and 4 patients in the placebo arm were excluded due to lack of primary efficacy data at Visit 7. | Posted | | Mean | Standard Deviation | Unitless back-transformed from log-scale | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG003 | Placebo (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| | Units | Counts |
|---|
| Participants | - OG00055
- OG00148
- OG00229
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.551± 1.715
- OG0010.506± 2.163
- OG0020.663± 1.511
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | = 0.5009 | | Estimated ratio | 1.091 | | | 2-Sided | 95 | 0.845 | 1.408 | | | | | Superiority | | | | | Mixed Models Analysis | | = 0.0078 |
|
| Secondary | Change in IDAA1c | Change in insulin-dose-adjusted HbA1c (IDAA1c) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Mean | Standard Deviation | Percent of glycated hemoglobin | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
|
| Secondary | Change in HbA1c | Change in HbA1c (mmol/mol) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. | Posted | | Mean | Standard Deviation | mmol/mol | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG003 |
|
| Secondary | Change in Insulin Consumption | Change in daily exogenous insulin consumption (IU) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Mean | Standard Deviation | IU/kg/24h | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | |
|
| Secondary | Change in Glycemic Variability/Fluctuations | Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period. | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Mean | Standard Deviation | glycemic variability/fluctuation per day | | Screening and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
|
| Secondary | Percentage of Patients With IDAA1c ≤ 9 | Percentage of patients with IDAA1c ≤ 9 | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Number | 95% Confidence Interval | Percent of patients | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
|
| Secondary | Stimulated Maximum C-peptide Above 0.2 Nmol/L | Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Number | 95% Confidence Interval | Percent of patients | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
|
| Secondary | Stimulated C-peptide Above 0.2 Nmol/L at 90 Min | Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Number | 95% Confidence Interval | Percent of patients | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
|
| Secondary | Number of Hypoglycemias | Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts) | Safety Analysis Set, consist of all randomized patients who received at leastone injection. | Posted | | Number | | Episodes | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG003 |
|
| Secondary | Number of Patients Having at Least 1 Severe Hypoglycemic Event | Number of patients having at least 1 severe hypoglycemic event (counts) | Safety Analysis Set, consist of all randomized patients who received at leastone injection. | Posted | | Count of Participants | | Participants | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG003 | Placebo (HLA DR3-DQ2) |
|
| Secondary | Change in Maximum C-peptide | Change in maximum C-peptide during MMTT (nmol/L) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | |
|
| Secondary | Change in Fasting C-peptide | Change in Fasting C-peptide (nmol/L) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | |
|
| Secondary | C-peptide Levels During a MMTT | C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Mean | Standard Deviation | nmol/L | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) | | OG002 | Active (HLA DR3-DQ2) | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
|
| Secondary | Change in Body Weight | Change in body weight (kg) | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. | Posted | | Mean | Standard Deviation | Kg | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | Injection Site Reactions | | Safety Analysis Set, consist of all randomized patients who received at leastone injection. | Posted | | Number | | number of episodes | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis. | Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts) | Safety Analysis Set, consist of all randomized patients who received at least one injection. | Posted | | Number | | number of significant abnormal results | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations | Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal [including reflexes]). Standardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex. The outcome of the assessments was recored as "normal" or "abnormal" | Safety Analysis Set, consist of all randomized patients who received at leastone injection. | Posted | | Number | | Clinically significant abnormal results | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | GAD65A Titer | | Safety Analysis Set, consist of all randomized patients who received at leastone injection. | Posted | | Mean | Standard Deviation | IU/mL | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | Number of Clinically Significant Abnormal Results in Vital Signs | Vital signs (blood pressure) (mmHg) | Safety Analysis Set, consist of all randomized patients who received at leastone injection. | Posted | | Number | | Clinically significant abnormal results | | 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | Change in Quality of Life (QoL) | Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead. | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. Patients with missing data are excluded. | Posted | | Median | Inter-Quartile Range | Index value | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |
| Secondary | Change in Body Mass Index (BMI) | | Full analysis set, consist of all randomized patients who have received at least one dose of study medication and have at least one postbaseline assessment and corresponding baseline measurement of any efficacy variable. | Posted | | Mean | Standard Deviation | kg/m2 | | Baseline and 15 months | | | | ID | Title | Description |
|---|
| OG000 | Active Arm | Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) | | OG001 | Placebo Arm | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (GAD-alum) on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
| |