DiaPrecise, A Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals at Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

开始日期2024-07-09

申办/合作机构

Diamyd Medical AB

CTIS2024-513350-30-00

/ Recruiting临床2期

DiaPrecise, A Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® in individuals at risk for Type 1 diabetes carrying the HLA DR3-DQ2 haplotype

开始日期2024-07-09

申办/合作机构

Diamyd Medical AB

CTIS2023-509021-53-00

/ Not yet recruiting临床2期IIT

A follow-up project on the GADinLADA trial to test for the continued impact of HLA-DR3DQ2 on diabetes status and immune parameters 3 years after treatment with intranodal GAD-alum.

开始日期2024-05-01

申办/合作机构

Norwegian University of Science & Technology

100 项与 Retogatein 相关的临床结果

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100 项与 Retogatein 相关的转化医学

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100 项与 Retogatein 相关的专利（医药）

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项与 Retogatein 相关的文献（医药）

2025-08-01·JOURNAL OF IMMUNOLOGICAL METHODS

Development and performance evaluation of a novel, fully automated, high-throughput GAD65 autoantibody assay on the Phadia platform

Article

作者: Ettner, Virginie ; Filchtinski, Daniel ; Kayser, José ; Holz, Sanja ; Kristensen, Bjarne ; Fiedler, Raimund ; Schulte-Pelkum, Johannes ; Wilhelm, Isabel

OBJECTIVES:

In clinics, diabetes is determined by blood glucose levels or by glycosylated hemoglobin (HbA1c). However, to distinguish between Type 1 and Type 2 diabetes (T1D and T2D) for adequate treatment, patients are tested for the presence of Type 1 diabetes-relevant autoantibodies in the second tier. Anti-GAD65 autoantibody is one of the main markers for T1D in both pediatric and adult T1D patients. If the anti-GAD65 autoantibody is detectable, the patients have type 1 diabetes and need to be treated with insulin. In the clinical routine diagnostics of type 1 diabetes, GAD65-serology is performed using a special assay architecture known as bridging ELISA. Adapting these assays onto automated ELISA systems has shown to be a constant challenge, so they can be hardly applied for high throughput testing in a routine clinical laboratory.

METHODS:

We developed the first fully automated, high-throughput GAD65 autoantibody fluorescence enzyme immunoassay based on the bridging immunoassay format on Phadia instrument platform, termed EliA GAD65 and compared its performance with the bridging ELISA from RSR™ (GADAb ELISA) and the fully automated MAGLUMI® GAD65 chemiluminescence assay (CLIA) from Snibe Diagnostics.

RESULTS:

When tested for clinical performance, ROC Analysis of EliA GAD65 showed an Area under the curve (AUC) of 0.906 (95 % CI 0.864 to 0.949) compared to the AUC of 0.923 (95 % CI 0.884to 0.963) of GADAb ELISA with no significant difference between the two assays (p = 0.384). When adjusted to a specificity of 96 %, EliA GAD65 showed a sensitivity of 76 % (CI 95 % 66.4 % to 84.0 %) compared to a sensitivity of 74 % (95 % CI 64.6 % to 81.6 %) of GADAb ELISA. When the fully automated MAGLUMI® GAD65 CLIA was compared to GADAb ELISA, it showed a total agreement of 92.9 % (95 % CI 86.6 % to 96.4 %) with less positive samples detected in contrast to the total agreement of 100 % (95 % CI 96.7 % to 100 %) of EliA GAD65 to GADAb ELISA.

CONCLUSIONS:

Fully automated EliA GAD65 assay displays similar clinical characteristics as the well-established bridging GADAb ELISA and a higher agreement with the GADAb ELISA than the automated MAGLUMI® GAD65 CLIA.

2023-11-01·Diabetes, obesity & metabolism

A 1‐year pilot study of intralymphatic injections of GAD‐alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes

Article

作者: Ludvigsson, Johnny ; Hals, Ingrid K. ; Grill, Valdemar ; Björklund, Anneli ; Balasuriya, Chandima ; Casas, Rosaura

Abstract:

Aims:

To test, for the first time in latent autoimmune diabetes in adults (LADA), the effects of autoantigen‐specific immunotherapy by intralymphatic administration of aluminium‐formulated recombinant human glutamic acid decarboxylase 65 (GAD‐alum); specifically, to test if this treatment is safe, to test whether it induces a strong immunological response akin to a similar protocol in type 1 diabetes and to look for associations with preserved beta‐cell function.

Materials and Methods:

Three GAD‐alum injections, 4 μg each, were administered 1 month apart into an inguinal lymph node in 14 people with newly diagnosed LADA (age 30‐62 years) presenting with high levels of antibodies against glutamic acid decarboxylase (GADA). Adverse effects, immunological variables and beta‐cell function were monitored, with detailed measurements at 5 and 12 months from baseline.

Results:

Clinical adverse effects were minor and transient and measured laboratory variables were unaffected. All participants completed the study. Treatment raised levels of GADA, elicited strong effects on reactivity of peripheral blood mononuclear cells to GAD and raised cytokine/chemokine levels. Beta‐cell function appeared stable preferentially in the seven participants carrying human leukocyte antigen (HLA) haplotypes DR3DQ2, as assessed by C‐peptide glucagon tests ( P < 0.05 vs. seven non‐carriers).

Conclusion:

Intralymphatic treatment with GAD‐alum in LADA is without clinical or other safety concerns over a 12‐month period. As in a similar protocol used in type 1 diabetes, treatment exerts a strong immunological impact and is compatible with protection of beta‐cell function preferentially in HLA‐DR3DQ2 LADA patients. These findings pave the way for a randomized controlled trial in this important subgroup of LADA patients.

2022-10-01·BMJ open

Phase III, randomised, double-blind, placebo-controlled, multicentre trial to evaluate the efficacy and safety of rhGAD65 to preserve endogenous beta cell function in adolescents and adults with recently diagnosed type 1 diabetes, carrying the genetic HLA DR3-DQ2 haplotype: the DIAGNODE-3 study protocol

Article

作者: Casas, Rosaura ; Nowak, Christoph ; Lind, Marcus ; Eriksson, Linnea ; Widman, Martina ; Teixeira, Pedro F ; Lindqvist, Anton ; Hannelius, Ulf ; Ludvigsson, Johnny

Introduction:

Type 1 diabetes (T1D) is an autoimmune disease leading to the destruction of the insulin-producing beta cells resulting in insulin deficiency and hyperglycaemic. Today, no approved therapy exists to halt this detrimental immunologic process. In a recent phase 2b study, intralymphatic administration of recombinant human glutamic acid decarboxylase 65 kDa (rhGAD65) adsorbed to Alhydrogel adjuvant to individuals recently diagnosed with T1D and carrying the HLA DR3-DQ2 haplotype showed promising results in preserving endogenous insulin secretion, confirming the results of a large meta-analysis of three randomised placebo-controlled trials of subcutaneous rhGAD65. The aim of the current precision medicine phase 3 study is to determine whether intralymphatic administration of rhGAD65 preserves insulin secretion and improves glycaemic control in presumed responder individuals with recently diagnosed T1D carrying HLA DR3-DQ2.

Methods and analysis:

Individuals ≥12 and <29 years recently diagnosed with T1D (<6 months) will be screened for the HLA DR3-DQ2 haplotype, endogenous insulin production estimated by fasting C-peptide and presence of GAD65 antibodies. 330 patients are planned to be randomised to 3 monthly intralymphatic injections of rhGAD65 or placebo (both accompanied by oral vitamin D supplementation), followed by 22 months of follow-up. The study is powered to detect a treatment effect in the two coprimary endpoints; change from baseline in AUC (0-120min) C-peptide levels during a mixed meal tolerance test, and change from baseline in glycaemic control estimated by haemoglobin A1c at 24 months. Secondary endpoints include effects on glucose patterns collected by masked continuous glucose monitoring, proportion of patients in partial remission and number of episodes of severe hypoglycaemia and/or diabetic ketoacidosis.

Ethics and dissemination:

The trial is approved by Ethics Committees in Poland (124/2021), the Netherlands (R21.089), Sweden (2021-05063), Czech Republic (EK-1144/21), Germany (2021361) and Spain (21/2021). Results will be published in international peer-reviewed scientific journals and presented at national and international conferences.

Trial registration number:

EudraCT identifier: 2021-002731-32, NCT identifier: NCT05018585 .

项与 Retogatein 相关的新闻（医药）

2026-02-24

·PRNewswire

Diamyd Medical announces finalization of database for interim analysis in Phase 3 DIAGNODE-3 trial

STOCKHOLM, Feb. 24, 2026 /PRNewswire/ -- The clinical database has been finalized for the pre-specified interim efficacy analysis in Diamyd Medical's ongoing pivotal Phase 3 trial (DIAGNODE-3) evaluating retogatein (rhGAD65) in individuals with Stage 3 type 1 diabetes. The outcome of interim analysis readout is expected by the end of March 2026. "This is a key milestone in DIAGNODE-3 and for our precision medicine strategy in type 1 diabetes," says Ulf Hannelius, President and CEO of Diamyd Medical. "The interim analysis will provide the first Phase 3 assessment of retogatein's potential to preserve insulin production in a genetically defined patient population." The interim analysis is based on data from 174 evaluable participants. The primary endpoint of the interim analysis is change from baseline to Month 15 in stimulated C-peptide area under the curve (AUC), reflecting preservation of endogenous insulin production, and is intended to provide an assessment of treatment effect in the study population. In line with the company's regulatory strategy, positive interim result would support engagement with regulatory authorities to discuss possible approval pathways for retogatein. The interim analysis will assess the efficacy of retogatein compared to placebo and test whether predefined criteria for statistical significance are met. An independent Data Safety Monitoring Board (DSMB) will review the interim result and accumulated safety data. The company intends to communicate the outcome of the DSMB meeting, including whether statistical significance was met for the primary endpoint, as well as an update on the DSMB's safety assessment of the ongoing trial. DIAGNODE-3 is a randomized, double-blind, placebo-controlled confirmatory Phase 3 trial evaluating intralymphatic administration of retogatein formulated with alum in children, adolescents, and young adults newly diagnosed with Stage 3 type 1 diabetes who carry the HLA DR3-DQ2 haplotype. This genetic profile is present in approximately 40% of individuals with type 1 diabetes in Europe and the United States. The primary readout will be based on baseline to 15-month data for all randomized participants after which participants will continue to be followed for a total of 24 months. DIAGNODE-3 is expected to be fully randomized in mid-March 2026. DIAGNODE-3 is supported, in part, by funding from Breakthrough T1D (formerly JDRF), the leading global type 1 diabetes research and advocacy organization. Retogatein has received Fast Track Designation from the FDA for the treatment of type 1 diabetes across Stages 1-3, as well as Orphan Drug Designation for Stage 3 type 1 diabetes. About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US, is being conducted at 57 clinics in eight European countries and in the US in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB. Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser. CONTACT: For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB 21% more press release views with Request a Demo

临床2期孤儿药快速通道临床3期免疫疗法

2026-02-09

·PRNewswire

Diamyd Medical receives Notice of Allowance for key retogatein US patent

STOCKHOLM, Feb. 9, 2026 /PRNewswire/ -- Diamyd Medical today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent covering the intralymphatic administration of retogatein (rhGAD65) with alum for the prevention and treatment of type 1 diabetes. The now allowed U.S. application is part of a patent family with corresponding rights already granted in Europe, Australia, Hong Kong, China, Canada, South Africa, Japan, Russia, and Israel. Upon grant, the U.S. patent will further strengthen Diamyd Medical's international patent protection for a key component of its antigen-specific immunotherapy platform. The patent, when issued, will have an anticipated expiration date in 2035. "This Notice of Allowance further strengthens our global intellectual property for our precision medicine and antigen-specific immunotherapy in type 1 diabetes," says Ulf Hannelius, President and CEO of Diamyd Medical. "Securing patent protection in the U.S. is a key milestone as retogatein advances toward potential commercialization." The intralymphatic administration method protected by the patent is being used in the ongoing confirmatory Phase 3 DIAGNODE-3 trial in children, adolescents, and adults with newly diagnosed Stage 3 type 1 diabetes. An FDA-aligned interim efficacy readout from the trial is expected end of March 2026. As a biological product, retogatein is eligible for regulatory market exclusivity in the United States and Europe, independent of patent protection, subject to regulatory approval. About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US, is being conducted at 57 clinics in eight European countries and in the US in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB. Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser. For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB 21% more press release views with Request a Demo

孤儿药免疫疗法临床2期临床3期快速通道

2026-02-04

·生物通

抗GAD抗体相关性癫痫的预后因素及初步预后模型

抗谷氨酸脱羧酶抗体相关癫痫的预后预测模型构建与临床意义分析1. 研究背景与现状抗谷氨酸脱羧酶抗体（GAD65）相关神经免疫疾病谱系涵盖癫痫、脑炎、 stiff-person综合征等多种临床表现。其中以GAD-EP（抗体阳性癫痫）和GAD-LE（抗体阳性脑炎）最为常见，二者在临床表现和免疫机制上存在显著重叠。尽管ILAE（国际抗癫痫联盟）2025年已将GAD-EP列为独立诊断亚型，但现有指南对预后评估缺乏量化工具。临床数据显示，约75%的GAD-EP患者经免疫治疗联合抗癫痫药物后仍无法实现长期 seizure freedom（ seizure freedom定义为持续12个月以上的无发作状态），这一现象凸显了建立精准预后评估体系的必要性。2. 研究方法与数据采集研究采用多中心回顾性队列设计，纳入201X-2024年间经GAD65抗体确诊的癫痫患者。数据采集涵盖四大维度：- 人口统计学：年龄、性别、病程持续时间- 临床特征：发作类型（局灶性/弥漫性）、发作频率（每日/每周/每月）、共病情况（甲状腺疾病、糖尿病等）- 免疫学指标：外周血CD8+ T细胞计数、免疫球蛋白水平（IgG/IgA/IgM）- 影像学特征：MRI异常（颞叶萎缩/低代谢灶）、脑脊液细胞计数通过严格排除标准（CSF抗体检测阴性、随访不足12个月等），最终形成包含91例样本的临床数据库。该样本量虽相对有限，但通过分层抽样确保了不同亚型（GAD-EP与GAD-LE）的平衡性，其中TLE（颞叶癫痫）占63%，音乐性癫痫占6%，形成具有代表性的研究队列。3. 关键预后因素分析3.1 患者分层特征- 性别分布：女性占比79.1%（71/91），与中枢神经系统抗体相关疾病性别偏向一致- 疾病亚型：GAD-EP占90%（82/91），GAD-LE占10%（9/91），二者在预后上未显示统计学差异（p=1.0）- 发作特征：局灶性发作患者中76.5%出现持续癫痫状态，显著高于非局灶组（p=0.004）- 影像学特征：58%患者存在颞叶结构性异常（萎缩/低代谢），但未达显著预后区分阈值（p=0.411）3.2 关键预测因子识别3.2.1 负面预测指标- 颞叶癫痫（TLE）：风险比（OR）达0.098，提示TLE患者获得 seizure freedom的概率仅为非TLE组的9.8%- 每月≥1次发作：OR=0.067，显示高频发作显著增加治疗抵抗- 局灶性发作模式：与TLE形成复合负面因素，使预后风险倍增（p=0.004）- 音乐性癫痫：虽未达统计显著（p>0.05），但所有5例均表现为治疗抵抗3.2.2 正面预测指标- 疾病持续时间＜8个月：早期诊断显著改善预后（p=0.025）- 免疫治疗启动时间＜4个月：时间窗内治疗可使有效率提升（p=0.005）- 外周CD8+ T细胞计数＞619.5/μL：细胞免疫活性增强与预后改善相关（p=0.035）4. 预测模型构建与验证4.1 模型架构基于多元逻辑回归构建二分类预测模型，核心变量包括：- 预测因子：TLE状态（二分类变量）、月发作频率（连续变量）- 调节变量：年龄、共病情况、免疫治疗类型4.2 性能验证- 模型区分度：AUC=0.807（95%CI:0.696-0.919）- 阈值优化：当截断值设为0.238时，敏感度81.8%，特异度72.5%- 集中式验证：Hosmer-Lemeshow检验显示良好校准（χ2=0.124，p=0.740）- 稳定性验证：通过1000次自助法内效验，Brier评分稳定在0.1234.3 风险分层体系建立0-2分的三级风险评分：- 低风险（0分）：非TLE+低频发作（8.7%占比），预期seizure freedom达91.3%- 中风险（1-2分）：TLE+低频（49.3%占比）或非TLE+高频（58.9%占比），预后中间态- 高风险（2分）：TLE+高频（93.6%占比），仅6.4%实现seizure freedom5. 临床转化价值5.1 治疗决策支持- 低风险患者：推荐标准免疫治疗方案（激素+IVIG）- 高风险患者：需启动替代治疗方案（B细胞耗竭剂/靶向免疫治疗）- 中风险患者：建议延长观察期（＞24个月）或联合神经调控治疗5.2 预防策略优化- 建立抗体筛查时间窗：确诊后3个月内启动免疫治疗可提升有效率（p=0.005）- CD8+ T细胞动态监测：建议每3个月复查细胞计数，阈值＞750/μL时提示治疗敏感性- 影像学评估标准化：建议在确诊后6个月内完成高分辨率MRI+FDG-PET联合检查6. 研究局限性及改进方向6.1 样本特征限制- 东亚人群为主（占比＞85%），缺乏种族差异研究- 病例纳入截止2024年9月，未覆盖新型生物制剂时代数据6.2 验证体系待完善- 外部验证缺失：需在欧美人群（GAD-EP占比约15%）开展多中心验证- 预测因子动态变化：未追踪CD8+ T细胞计数随治疗时间的变化趋势- 生物标志物组合：建议纳入CSF炎症指标（如IL-6、sIL-2R）进行模型优化6.3 治疗策略瓶颈- 免疫治疗方案同质性：78%患者采用激素+IVIG组合，缺乏剂量优化研究- 替代疗法储备不足：仅23%患者尝试二线治疗（B细胞耗竭剂）- 手术指征模糊：2例行颞叶切除术患者均未达到seizure freedom7. 未来研究方向7.1 生物标志物开发- 探索CD8+ T细胞亚群分型（如耗竭性/效应性T细胞比例）- 建立CSF免疫微环境分析平台（含细胞因子谱、外泌体特征）7.2 治疗反应预测- 构建动态预测模型：整合治疗过程中免疫指标变化- 开发液体活检技术：通过外周血循环肿瘤DNA（ctDNA）监测神经炎症状态7.3 多模态验证体系- 建立GAD-EP生物信息学平台：整合基因组（如HLA基因型）、蛋白质组（如细胞因子网络）和代谢组数据- 引入神经影像AI分析：开发自动识别颞叶病变进展的深度学习模型8. 社会医学价值研究揭示GAD-EP患者存在显著预后异质性，这直接关系到：- 医保报销政策：高风险患者可能需要覆盖新型生物制剂（如IL-17单抗）- 保险精算模型：基于风险分层可建立差异化保费体系- 患者教育策略：针对高风险群体开展早期手术/替代治疗宣导该研究首次系统建立GAD-EP预后预测框架，其临床转化价值体现在：- 风险分层指导治疗强度选择：低风险患者可常规治疗，高风险需升级干预- 动态监测指标：CD8+ T细胞计数可作为疗效预测指标- 影像学解读规范：建议在确诊后6个月内完成高分辨率影像评估研究不足主要集中于样本代表性（东亚人群为主）和验证体系（缺乏外部队列验证）。后续研究应着重于建立多中心跨国队列，同时探索将脑电图特征（如r波振幅）和生物标志物进行多变量模型融合，这将为精准医疗提供更全面的决策支持。

免疫疗法临床结果临床研究

100 项与 Retogatein 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB04963

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床3期	芬兰	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	法国	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	德国	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	意大利	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	荷兰	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	斯洛文尼亚	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	西班牙	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	瑞典	Diamyd Medical AB	2008-07-01
1型糖尿病	临床3期	英国	Diamyd Medical AB	2008-07-01
糖尿病前期	临床2期	瑞典	Diamyd Medical AB	2022-12-12

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04262479 (GADinLADA, CTgov)	临床2期	成人隐匿性自身免疫性糖尿病	14	recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel+Vitamin D	鬱遞餘網壓範鬱襯鬱窪 = 鑰鏇憲鬱醖窪鑰襯襯窪積衊築顧夢膚觸鏇構製 (製蓋膚網網鹽壓糧衊網, 廠積壓獵選廠醖蓋艱遞 ~ 願選遞淵範遞襯願構糧) 更多	-	2025-06-08
NCT03345004 (DIAGNODE-2, CTgov)	临床2期	1型糖尿病	109	Vitamin D+Diamyd (Active Arm)	廠範鹽窪鑰築鹹選蓋鹽(醖夢範窪夢觸窪蓋選獵) = 範觸襯鑰積膚憲襯廠簾餘鹹鬱選遞積憲壓鏇膚 (醖築製窪繭餘選膚鹹鹽, 1.715) 更多	-	2023-01-09
NCT03345004 (DIAGNODE-2, CTgov)	临床2期	1型糖尿病	109	Placebo for Diamyd (Placebo Arm)	廠範鹽窪鑰築鹹選蓋鹽(醖夢範窪夢觸窪蓋選獵) = 網衊範願鹽淵窪膚鬱鏇餘鹹鬱選遞積憲壓鏇膚 (醖築製窪繭餘選膚鹹鹽, 2.163) 更多	-	2023-01-09
NCT02352974 (DIAGNODE \| DIAGNODE-1, CTgov)	临床1期	1型糖尿病	12	Vitamin D+GAD-Alum	遞壓窪顧構遞鏇網範範 = 築壓憲憲憲選鑰製壓遞鹹積蓋網獵襯網獵醖繭 (淵簾遞廠鏇遞憲選糧蓋, 襯艱鬱衊鹹願窪觸壓鬱 ~ 糧餘衊顧齋醖觸鑰艱鹹) 更多	-	2020-04-27
NCT02352974 (DIAGNODE-1, Biospace) 人工标引	临床1/2期	1型糖尿病	12	Diamyd	艱憲糧夢簾憲獵憲遞鹹(憲獵憲獵壓廠簾構窪廠) = 築構繭築繭蓋簾網繭鑰膚鹹憲鏇顧襯選餘製鏇 (繭夢廠遞衊製齋鹹鏇願 ) 更多	积极	2019-12-20
NCT02464033 (CTgov)	临床2期	1型糖尿病	20	Vitamin D+Etanercept	艱選餘憲襯築糧鏇遞網 = 醖廠鬱獵鏇壓遞糧夢範鏇鹽廠夢鬱廠齋廠蓋獵 (鑰蓋壓網窪窪繭醖積淵, 鬱積艱鏇夢衊壓廠積獵 ~ 糧艱膚艱憲襯獵齋餘糧) 更多	-	2019-09-25
NCT01122446 (DIAPREV-IT, CTgov)	临床2期	1型糖尿病 \| 糖尿病前期	50	Placebo comparator (Placebo Comparator)	築衊壓鹹觸構網製獵繭 = 選餘願鬱齋鏇醖顧積鑰範艱壓願範選齋積鬱願 (醖選壓積窪製夢淵壓餘, 壓選醖艱衊觸鹽繭遞願 ~ 範願鹹鬱顧遞鑰艱鑰觸) 更多	-	2019-05-06
NCT01122446 (DIAPREV-IT, CTgov)	临床2期	1型糖尿病 \| 糖尿病前期	50	Diamyd (Alum-GAD (Diamyd))	築衊壓鹹觸構網製獵繭 = 簾製築糧膚蓋鬱構觸範範艱壓願範選齋積鬱願 (醖選壓積窪製夢淵壓餘, 遞鬱膚齋餘築範衊選襯 ~ 製淵鹽襯鹹窪遞餘選襯) 更多	-	2019-05-06
NCT00529399 (TN08, CTgov)	临床2期	1型糖尿病	145	GAD-Alum (GAD-alum)	遞廠積鑰獵窪簾構糧顧(齋選鹹蓋觸齋築糧願窪) = 觸簾餘淵鹽醖範鑰範鹽憲壓壓觸淵獵醖艱膚齋 (製構襯窪壓選顧蓋憲繭, 齋遞夢願鬱遞艱繭選鬱 ~ 衊醖鹽選蓋淵夢衊蓋憲) 更多	-	2016-12-07
NCT00529399 (TN08, CTgov)	临床2期	1型糖尿病	145	Alum (GAD-alum Plus Alum)	遞廠積鑰獵窪簾構糧顧(齋選鹹蓋觸齋築糧願窪) = 齋膚築窪觸鬱簾淵夢鹹憲壓壓觸淵獵醖艱膚齋 (製構襯窪壓選顧蓋憲繭, 艱廠蓋憲鑰憲廠製醖淵 ~ 製鹹顧鬱鬱選壓憲繭顧) 更多	-	2016-12-07
NCT00837759 (CTgov)	临床2期	1型糖尿病	7	Insulin+Sitagliptin+Lansoprazole+GAD65	顧遞構鏇構餘齋齋構糧(鹹顧構憲築鏇構壓鹽構) = 襯廠網構蓋糧襯夢糧廠醖積壓襯鹽糧鑰築夢遞 (遞夢淵齋淵顧鏇齋鹽繭, 0.53) 更多	-	2012-10-24