Safety and efficacy of autoantigen‐specific therapy with 2 doses of alum‐formulated glutamate decarboxylase in children with multiple islet autoantibodies and risk for type 1 diabetes: A randomized clinical trial
Objective Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen‐specific treatment with alum‐formulated glutamate decarboxylase (GAD‐Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmu...
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| Vydáno v: | Pediatric diabetes Ročník 19; číslo 3; s. 410 - 419 |
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| Hlavní autoři: | , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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Former Munksgaard
John Wiley & Sons A/S
01.05.2018
John Wiley & Sons, Inc |
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| ISSN: | 1399-543X, 1399-5448, 1399-5448 |
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| Abstract | Objective
Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen‐specific treatment with alum‐formulated glutamate decarboxylase (GAD‐Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmunity.
Methods
In an investigator‐initiated, double‐blind, placebo‐controlled clinical trial, non‐diabetic children aged 4 to 17.9 years with autoantibodies to glutamate decarboxylase (GADA) and at least one of insulinoma‐associated protein 2, insulin or zinc‐transporter 8, were randomized, stratified by 2 or ≥3 islet autoantibodies, to 2 injections of 20 μg GAD‐Alum or placebo, 30 days apart. Main outcome was safety, investigated by adverse events, hematology, chemistry, thyroid and celiac autoimmunity and titers of islet autoantibodies, and efficacy, investigated by cumulative incidence of diabetes onset over 5‐year follow‐up. Secondary variables: change in first‐phase insulin release (FPIR) after intravenous glucose tolerance tests, fasting, 120 minutes and Area under the curve (AUC) C‐peptide and p‐glucose after oral glucose tolerance tests and HbA1c.
Results
Fifty children (median age: 5.2) were assigned 1:1 to GAD‐Alum or placebo, all receiving full treatment and included in the analyses. GAD‐Alum did not affect any safety parameter, while GADA titers increased (P = .001). Time to clinical diagnosis was not affected by treatment (hazard ratio, HR = 0.77, P = .574) in the full population or in the separate stratum groups. Treatment did not affect any of the secondary variables.
Conclusions
GAD‐Alum as a subcutaneous prime and boost injection was safe in prediabetic young children but did not affect progression to type 1 diabetes. The safety of GAD‐Alum should prove useful in future prevention studies. |
|---|---|
| AbstractList | Objective
Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen‐specific treatment with alum‐formulated glutamate decarboxylase (GAD‐Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmunity.
Methods
In an investigator‐initiated, double‐blind, placebo‐controlled clinical trial, non‐diabetic children aged 4 to 17.9 years with autoantibodies to glutamate decarboxylase (GADA) and at least one of insulinoma‐associated protein 2, insulin or zinc‐transporter 8, were randomized, stratified by 2 or ≥3 islet autoantibodies, to 2 injections of 20 μg GAD‐Alum or placebo, 30 days apart. Main outcome was safety, investigated by adverse events, hematology, chemistry, thyroid and celiac autoimmunity and titers of islet autoantibodies, and efficacy, investigated by cumulative incidence of diabetes onset over 5‐year follow‐up. Secondary variables: change in first‐phase insulin release (FPIR) after intravenous glucose tolerance tests, fasting, 120 minutes and Area under the curve (AUC) C‐peptide and p‐glucose after oral glucose tolerance tests and HbA1c.
Results
Fifty children (median age: 5.2) were assigned 1:1 to GAD‐Alum or placebo, all receiving full treatment and included in the analyses. GAD‐Alum did not affect any safety parameter, while GADA titers increased (P = .001). Time to clinical diagnosis was not affected by treatment (hazard ratio, HR = 0.77, P = .574) in the full population or in the separate stratum groups. Treatment did not affect any of the secondary variables.
Conclusions
GAD‐Alum as a subcutaneous prime and boost injection was safe in prediabetic young children but did not affect progression to type 1 diabetes. The safety of GAD‐Alum should prove useful in future prevention studies. Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen-specific treatment with alum-formulated glutamate decarboxylase (GAD-Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmunity.OBJECTIVETreatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen-specific treatment with alum-formulated glutamate decarboxylase (GAD-Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmunity.In an investigator-initiated, double-blind, placebo-controlled clinical trial, non-diabetic children aged 4 to 17.9 years with autoantibodies to glutamate decarboxylase (GADA) and at least one of insulinoma-associated protein 2, insulin or zinc-transporter 8, were randomized, stratified by 2 or ≥3 islet autoantibodies, to 2 injections of 20 μg GAD-Alum or placebo, 30 days apart. Main outcome was safety, investigated by adverse events, hematology, chemistry, thyroid and celiac autoimmunity and titers of islet autoantibodies, and efficacy, investigated by cumulative incidence of diabetes onset over 5-year follow-up. Secondary variables: change in first-phase insulin release (FPIR) after intravenous glucose tolerance tests, fasting, 120 minutes and Area under the curve (AUC) C-peptide and p-glucose after oral glucose tolerance tests and HbA1c.METHODSIn an investigator-initiated, double-blind, placebo-controlled clinical trial, non-diabetic children aged 4 to 17.9 years with autoantibodies to glutamate decarboxylase (GADA) and at least one of insulinoma-associated protein 2, insulin or zinc-transporter 8, were randomized, stratified by 2 or ≥3 islet autoantibodies, to 2 injections of 20 μg GAD-Alum or placebo, 30 days apart. Main outcome was safety, investigated by adverse events, hematology, chemistry, thyroid and celiac autoimmunity and titers of islet autoantibodies, and efficacy, investigated by cumulative incidence of diabetes onset over 5-year follow-up. Secondary variables: change in first-phase insulin release (FPIR) after intravenous glucose tolerance tests, fasting, 120 minutes and Area under the curve (AUC) C-peptide and p-glucose after oral glucose tolerance tests and HbA1c.Fifty children (median age: 5.2) were assigned 1:1 to GAD-Alum or placebo, all receiving full treatment and included in the analyses. GAD-Alum did not affect any safety parameter, while GADA titers increased (P = .001). Time to clinical diagnosis was not affected by treatment (hazard ratio, HR = 0.77, P = .574) in the full population or in the separate stratum groups. Treatment did not affect any of the secondary variables.RESULTSFifty children (median age: 5.2) were assigned 1:1 to GAD-Alum or placebo, all receiving full treatment and included in the analyses. GAD-Alum did not affect any safety parameter, while GADA titers increased (P = .001). Time to clinical diagnosis was not affected by treatment (hazard ratio, HR = 0.77, P = .574) in the full population or in the separate stratum groups. Treatment did not affect any of the secondary variables.GAD-Alum as a subcutaneous prime and boost injection was safe in prediabetic young children but did not affect progression to type 1 diabetes. The safety of GAD-Alum should prove useful in future prevention studies.CONCLUSIONSGAD-Alum as a subcutaneous prime and boost injection was safe in prediabetic young children but did not affect progression to type 1 diabetes. The safety of GAD-Alum should prove useful in future prevention studies. Objective Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen‐specific treatment with alum‐formulated glutamate decarboxylase (GAD‐Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmunity. Methods In an investigator‐initiated, double‐blind, placebo‐controlled clinical trial, non‐diabetic children aged 4 to 17.9 years with autoantibodies to glutamate decarboxylase (GADA) and at least one of insulinoma‐associated protein 2, insulin or zinc‐transporter 8, were randomized, stratified by 2 or ≥3 islet autoantibodies, to 2 injections of 20 μg GAD‐Alum or placebo, 30 days apart. Main outcome was safety, investigated by adverse events, hematology, chemistry, thyroid and celiac autoimmunity and titers of islet autoantibodies, and efficacy, investigated by cumulative incidence of diabetes onset over 5‐year follow‐up. Secondary variables: change in first‐phase insulin release (FPIR) after intravenous glucose tolerance tests, fasting, 120 minutes and Area under the curve (AUC) C‐peptide and p‐glucose after oral glucose tolerance tests and HbA1c. Results Fifty children (median age: 5.2) were assigned 1:1 to GAD‐Alum or placebo, all receiving full treatment and included in the analyses. GAD‐Alum did not affect any safety parameter, while GADA titers increased (P = .001). Time to clinical diagnosis was not affected by treatment (hazard ratio, HR = 0.77, P = .574) in the full population or in the separate stratum groups. Treatment did not affect any of the secondary variables. Conclusions GAD‐Alum as a subcutaneous prime and boost injection was safe in prediabetic young children but did not affect progression to type 1 diabetes. The safety of GAD‐Alum should prove useful in future prevention studies. Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen-specific treatment with alum-formulated glutamate decarboxylase (GAD-Alum) was safe and affected progression to type 1 diabetes in children with islet autoimmunity. In an investigator-initiated, double-blind, placebo-controlled clinical trial, non-diabetic children aged 4 to 17.9 years with autoantibodies to glutamate decarboxylase (GADA) and at least one of insulinoma-associated protein 2, insulin or zinc-transporter 8, were randomized, stratified by 2 or ≥3 islet autoantibodies, to 2 injections of 20 μg GAD-Alum or placebo, 30 days apart. Main outcome was safety, investigated by adverse events, hematology, chemistry, thyroid and celiac autoimmunity and titers of islet autoantibodies, and efficacy, investigated by cumulative incidence of diabetes onset over 5-year follow-up. Secondary variables: change in first-phase insulin release (FPIR) after intravenous glucose tolerance tests, fasting, 120 minutes and Area under the curve (AUC) C-peptide and p-glucose after oral glucose tolerance tests and HbA1c. Fifty children (median age: 5.2) were assigned 1:1 to GAD-Alum or placebo, all receiving full treatment and included in the analyses. GAD-Alum did not affect any safety parameter, while GADA titers increased (P = .001). Time to clinical diagnosis was not affected by treatment (hazard ratio, HR = 0.77, P = .574) in the full population or in the separate stratum groups. Treatment did not affect any of the secondary variables. GAD-Alum as a subcutaneous prime and boost injection was safe in prediabetic young children but did not affect progression to type 1 diabetes. The safety of GAD-Alum should prove useful in future prevention studies. |
| Author | Jonsdottir, Berglind Lundgren, Markus Elding Larsson, Helena Cuthbertson, David Krischer, Jeffrey |
| Author_xml | – sequence: 1 givenname: Helena orcidid: 0000-0003-3306-1742 surname: Elding Larsson fullname: Elding Larsson, Helena email: helena.larsson@med.lu.se organization: Lund University – sequence: 2 givenname: Markus orcidid: 0000-0001-6394-7689 surname: Lundgren fullname: Lundgren, Markus organization: Lund University – sequence: 3 givenname: Berglind surname: Jonsdottir fullname: Jonsdottir, Berglind organization: Lund University – sequence: 4 givenname: David surname: Cuthbertson fullname: Cuthbertson, David organization: University of South Florida – sequence: 5 givenname: Jeffrey surname: Krischer fullname: Krischer, Jeffrey organization: University of South Florida |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29171140$$D View this record in MEDLINE/PubMed |
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| CorporateAuthor | for the DiAPREV‐IT Study Group DiAPREV-IT Study Group Lunds universitet Profile areas and other strong research environments Department of Clinical Sciences, Malmö Lund University Strategiska forskningsområden (SFO) EXODIAB: Excellence of Diabetes Research in Sweden Faculty of Medicine Strategic research areas (SRA) Medicinska fakulteten Pediatrisk endokrinologi Profilområden och andra starka forskningsmiljöer Institutionen för kliniska vetenskaper, Malmö Paediatric Endocrinology |
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Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen‐specific treatment... Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen-specific treatment with... Objective Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen‐specific treatment... OBJECTIVE: Treatments have failed to delay or stop the autoimmune process, preceding onset of type 1 diabetes. We investigated if autoantigen-specific... |
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| SubjectTerms | Aluminum sulfate Autoantibodies Autoimmunity Children Clinical Medicine Clinical trials Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) Endocrinology and Diabetes Endokrinologi och diabetes GAD‐Alum Glucose Glucose tolerance Glutamate decarboxylase Hematology Immunological tolerance Insulin Insulinoma Intravenous administration Klinisk medicin Medical and Health Sciences Medicin och hälsovetenskap Neuroendocrine tumors Pediatrics Pediatrik prevention Safety Thyroid type 1 diabetes |
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| Title | Safety and efficacy of autoantigen‐specific therapy with 2 doses of alum‐formulated glutamate decarboxylase in children with multiple islet autoantibodies and risk for type 1 diabetes: A randomized clinical trial |
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