DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen
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ClinicalTrials.gov Identifier: NCT01785108 |
Recruitment Status :
Completed
First Posted : February 7, 2013
Last Update Posted : August 23, 2017
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The objectives of this study is to
- evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
- evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections
- evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 1 | Biological: GAD-Alum (Diamyd) 20 µg Biological: GAD-Alum (Diamyd) 20 µg X 2 Drug: Vitamin D Drug: Ibuprofen | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
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Active Comparator: GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
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Biological: GAD-Alum (Diamyd) 20 µg Drug: Vitamin D Drug: Ibuprofen |
Active Comparator: GAD-Alum (Diamyd) 20µg and Vitamin D
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Biological: GAD-Alum (Diamyd) 20 µg Drug: Vitamin D |
Active Comparator: GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
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Biological: GAD-Alum (Diamyd) 20 µg X 2 Drug: Vitamin D |
Placebo Comparator: Placebo |
Biological: GAD-Alum (Diamyd) 20 µg X 2 Drug: Vitamin D Drug: Ibuprofen |
- Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30 [ Time Frame: 6 months, 15 months and 30 months ]
- Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L [ Time Frame: 6, 15 and 30 months ]
- Hemoglobin A1c (HbA1c), change between baseline and subsequent visits [ Time Frame: 6, 15 and 30 months ]
- Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits [ Time Frame: 6, 15 and 30 months ]
- Th2-deviation of cell-mediated immune response seen, e.g. as increased ratio of IL-5, 10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta, IL-17, and increase of T-regulatory cells [ Time Frame: 6, 15 and 30 months ]
- Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17 [ Time Frame: 6, 15 and 30 months ]
- Fasting C-peptide, change between baseline and month 6, 15 and 30 [ Time Frame: 6, 15 and 30 months ]

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Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- Male and female patients between 10 and 18 years of age
- Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening
- Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L
- Elevated GAD65 antibodies (GADA) at time of screening
Main Exclusion Criteria:
- Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin
- A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
- Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose
- Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785108
Sweden | |
Halmstad Hospital | |
Halmstad, Sweden, SE-301 85 | |
Astrid Lindgren Children's Hospital - Huddinge | |
Huddinge, Sweden, SE-141 86 | |
Kalmar Hospital | |
Kalmar, Sweden, SE-391 85 | |
Linköping University | |
Linköping, Sweden, SE-581 85 | |
Lund University Hospital | |
Lund, Sweden, SE-221 85 | |
Skåne University Hospital, UMAS | |
Malmö, Sweden, SE-205 02 | |
Sachsska, Södersjukhuset | |
Stockholm, Sweden, SE-118 83 | |
Astrid Lindgren Children's Hospital | |
Stockholm, Sweden, SE-171 76 | |
Uddevalla Hospital | |
Uddevalla, Sweden, SE-451 80 | |
Örebro University Hospital | |
Örebro, Sweden, SE-701 85 |
Principal Investigator: | Johnny Ludvigsson, MD,PhD,Prof | Linkoeping University |
Responsible Party: | Johnny Ludvigsson, MD, PhD, Professor, Linkoeping University |
ClinicalTrials.gov Identifier: | NCT01785108 |
Other Study ID Numbers: |
DIABGAD-1 |
First Posted: | February 7, 2013 Key Record Dates |
Last Update Posted: | August 23, 2017 |
Last Verified: | August 2017 |
Diamyd Diabetes Juvenile Diabetes Diabetes type 1 Autoimmune Diabetes Insulin dependent Diabetes Type 1 diabetes Type 1 diabetes mellitus rhGAD65 |
GAD GAD65 GAD-alum Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Vitamin D Ibuprofen |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Vitamin D Ibuprofen Aluminum sulfate Vitamins Micronutrients Nutrients Growth Substances |
Physiological Effects of Drugs Bone Density Conservation Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors |