GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1) (DIAGNODE)
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|ClinicalTrials.gov Identifier: NCT02352974|
Recruitment Status : Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : September 28, 2018
The objectives of the main study is to:
- Evaluate the safety of giving GAD-Alum (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen
- Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion.
The objective of the sub-study is to:
- Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal lymph gland in 3 adult patients from the main study
- Evaluate how the above mentioned treatment influences the immune system and endogenous insulin secretion.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: GAD-Alum Drug: Vitamin D||Phase 1|
Eligible patients will be treated with 4 µg GAD-Alum into an inguinal lymph gland at three occasions, with one month intervals in combination with Vitamin D (14 000 IU/week) for 4 months, starting 1 month prior to first GAD-Alum injection.
A sub-study will include three adult patients from the main study and evaluate safety after a fourth injection with 4 μg GAD-Alum into an inguinal lymph gland in combination with oral vitamin D intake. The Prolonged Extension Study Period is 12 months and will start 30,5 months after baseline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Pilot Trial in Adults With Recent-onset T1D to Evaluate the Safety, Diabetes Status and Immune Response of GAD-antigen (Diamyd®) Therapy Administered Into Lymph Nodes in Combination With an Oral Vitamin D Regimen|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals
Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days
Other Name: Diamyd
Drug: Vitamin D
- Safety of giving Diamyd directly into lymph glands in combination with an oral vitamin D regimen at Month 6 (main study period) and Month 15 and 30 (extension study period) [ Time Frame: 6 months ]Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching); Number of adverse events and number of participants with adverse events; Laboratory measurements (biochemistry and haematology), including Calcium and Vitamin D in serum; Urinalysis (microalbuminuria, creatinine); Physical examinations, including neurological assessments; GAD65AB titer (GADA)
- Change in immune system markers from baseline to Month 6 (main study period) and subsequent visits during the extension study period [ Time Frame: 6 months, 15 and 30 months ]Inflammatory markers, (e.g. TNF-alfa, IL-1 beta, IL-2, IL-17); Th2-deviation of cell-mediated immune response seen e.g. as increased ratio IL-5,10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta and IL-17; Regulatory T-cells
- C-peptide: Fasting, 90 minute value, and Area Under the Curve (mean 0-120 min) during an MMTT, change from baseline [ Time Frame: 6 months, 15 and 30 months ]
- Hemoglobin A1c (HbA1c), change from baseline [ Time Frame: 6 months, 15 and 30 months ]
- Exogenous insulin dose per kg body weight and 24 hours, change from baseline [ Time Frame: 6 months, 15 and 30 months ]
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): NCT02352974
|Principal Investigator:||Johnny Ludvigsson, Professor||Linkoeping University|