Research will still continue due to its safety.
Current treatments used in managing type 1 diabetes, such as insulin and pramlintide, do not cure or prevent the disease. However, clinical research is still actively searching for possible cures and prevention. Recently, a pilot study was conducted in order to evaluate the efficacy of Alum-GAD (Diamyd) as a potential vaccine for preventing type 1 diabetes. In this autoimmune disease, the immune system forms autoantibodies in response to certain autoantigens. Having autoantibodies, particularly to Glutamic acid decarboxylase (GAD), can increase a patient’s risk of developing type 1 diabetes.
The use of Alum-GAD in previous studies have suggested it may preserve beta cell function. Thus, investigators theorized immune tolerance to Alum-GAD vaccine injections would prevent or even delay the progression of type 1 diabetes.
DIAPREV-IT, a double-blind, investigator initiated study, enrolled 50 children between the ages of 4 and 18 (median age = 5.2 years old) who were at high risk of developing type 1 diabetes. High risk was defined as participants with positive GAD antibodies and at least one additional type 1 diabetes associated autoantibody (IA, 2Ab, ZnT8R/W/QAb or IAA). At randomization, 25 participants received 20 micrograms of Alum-GAD on days 1 and 30. The remaining 25 participants received a placebo injection on days 1 and 30. Intravenous and oral glucose tolerance tests were conducted together at baseline and alternated every six months for the 5-year followup period. Assessment of the safety of Alum-GAD was performed by physical examinations and documentation of adverse events.
The results, presented at the ADA 77th Scientific Sessions, indicated Alum-GAD was safe to use in children at high risk of developing type 1 diabetes. Researchers did not report any serious adverse events, nor did they observe an increase in the progression to type 1 diabetes. However, the study did not prevent or delay type 1 diabetes in these children (p = 0.573). In fact, 18 out of the 50 participants, or 36%, developed type 1 diabetes during the 5-year trial period. The authors also indicated that subgroup analysis could not be performed because 26 participants had impaired glucose tolerance at baseline while 24 participants did not.
Although the results of the study determined the Alum-GAD vaccine did not prevent or delay the progression of type 1 diabetes in high-risk children, investigators have not discontinued research. They believe Alum-GAD may still be a possible prevention when tested in various doses or in combination with other agents. Currently, there are four ongoing clinical trials exploring the use of Alum-GAD with a larger number of participants and an extended trial period; DIAGNODE-1, DiAPREV-IT 2, EDCR IIa and GABA/DIAMYD.
- At this time, type 1 diabetes can only be managed by insulin. There is no known prevention or cure yet.
- In this study, the use of the Alum-GAD vaccine (Diamyd) did not prevent or delay the progression of type 1 diabetes in high risk children.
- Research on Alum-GAD will still continue despite the disappointing results.
American Diabetes Association. Autoantigen GAD-Vaccine is Safe for Children at High Risk for Developing Type 1 Diabetes. Press Release. Available at: http://www.diabetes.org/newsroom/press-releases/2017/larsson-scientific-sessions-2017.html. Accessed June 21, 2017.
Joanna Martinez-Mendez, PharmD Candidate 2018, Lake Erie College of Osteopathic Medicine School of Pharmacy: FL Campus