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

NCT05018585

/ Active, not recruiting临床3期

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults With Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

开始日期2022-05-19

申办/合作机构

Diamyd Medical AB

NCT05351879

/ Completed临床1/2期IIT

A Phase I/II Open Label Pilot Study to Evaluate the Safety and Feasibility of an Additional Intralymphatic Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes

The objective of the study is to evaluate the feasibility and safety of administering a 4th or 5th intralymphatic booster dose of GAD-alum (Diamyd®) to T1D patients carrying HLA DR3-DQ2, who have earlier been treated with three or four intralymphatic doses of GAD-alum (Diamyd®) respectively.

开始日期2022-05-09

申办/合作机构

Diamyd Medical AB

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）

2026-07-27

·diamyd.com

Diamyd Medical Provides Update on Learnings from DIAGNODE-3 Interim Analysis

Review identifies potential contributing factors and informs future development considerations; no new safety concerns identified. The pre-specified interim analysis included 174 of 321 enrolled participants at 15 months after the first study injection. The primary efficacy analysis did not achieve statistical significance, and the pre-specified continuation criteria were not met. The Company is closing DIAGNODE-3 for futility in accordance with the trial’s pre-specified decision framework. No new safety concerns were identified in connection with the interim analysis or subsequent review. Diamyd Medical AB (publ) today provided an update on learnings from its internal and external review of the pre-specified interim efficacy analysis from the pivotal Phase 3 DIAGNODE-3 trial. The trial evaluated the investigational antigen-specific immunotherapy retogatein (rhGAD65) in individuals with recent-onset Stage 3 type 1 diabetes carrying the HLA DR3-DQ2 haplotype. As previously announced, the interim analysis included 174 of the 321 enrolled participants and assessed C-peptide at 15 months after the first study injection. The analysis did not demonstrate statistical significance on the primary efficacy endpoint. In addition, the pre-specified criteria for continuation of the trial were not met. Based on these results, the Company decided to close DIAGNODE-3 for futility. No safety concerns were identified. Since receiving the interim results, Diamyd Medical has conducted a structured review of trial conduct, drug product characteristics, administration procedures, and available clinical data. The review did not identify any single reason, cause or design flaw that explains the outcome. No material protocol violations were identified. Instead, the review identified several factors that may warrant consideration in the design of any future preventive or therapeutic clinical study. These observations are hypothesis-generating and should not be interpreted as established explanations for the outcome of DIAGNODE-3. • Treatment administration: Intralymphatic administration may be operationally demanding in a large, multicenter trial in which individual sites treat relatively few participants. Compiled evidence from clinical trials to date potentially favors the more robust subcutaneous administration method. Future protocols could consider enhanced training, documentation, and quality-control measures in case of intralymphatic administration of study drug. • Timing of treatment: Exploratory analyses, and experience from other studies for the treatment of recent onset Stage-3 Type-1 Diabetes, suggest that a shorter interval between diagnosis and first treatment may be of merit. The available subgroups in DIAGNODE-3 were small and did not support definitive conclusions. • Drug product potency: “The measured potency of the drug product used in DIAGNODE-3 appears to have been lower than that used in the preceding DIAGNODE-2 study. There was a clear immunological response resulting from exposure in DIAGNODE-3, and the clinical relevance of the difference in potency has not been established, but is a factor that should be considered in future trials.” • Exploratory subgroup findings: Numerical trends were observed in certain subgroups; however, these analyses were not powered for confirmatory inference and involved limited participant numbers. They should therefore be viewed as exploratory only. Taken together, the review supports several potential lessons for future study design of antigen-specific tolerization studies with GAD65 as the active product ingredient in individuals with recent onset Stage-3 Type-1 Diabetes, including strengthened controls around intralymphatic administration, evaluation of earlier treatment after diagnosis, and further refinement of drug-product potency assessment. Any future clinical development would require an appropriately designed prospective study and engagement with relevant regulatory authorities. “DIAGNODE-3 did not meet the pre-specified criteria required to continue, and we are acting on that result with scientific discipline and financial responsibility. Our review has not identified a single cause for the outcome, but it has generated important learnings regarding trial execution, treatment timing, and product characterization. These observations are exploratory and will require prospective validation. Retogatein has been administered to more than 1,000 participants across clinical studies, and no new safety concerns were identified in DIAGNODE-3. We will apply the lessons from this program as we evaluate strategic options for retogatein, our GAD65 manufacturing capabilities and the Company’s broader assets.” — Anders Essen-Möller, Interim CEO, Diamyd Medical Diamyd Medical’s GMP-certified biologics facility in Umeå continues its program and capabilities for the manufacture of recombinant GAD65 for investigational use. The Company is in parallel evaluating strategic opportunities related to its development assets, manufacturing platform, and potential partnerships. A decision to initiate a new clinical efficacy trial with retogatein for the prevention or treatment of AutoImmune Diabetes would be subject to scientific, regulatory, strategic, and financial assessment. Forward-looking statements This press release contains forward-looking statements, including statements regarding potential contributing factors to the DIAGNODE-3 outcome, possible future development activities, manufacturing opportunities, partnerships, and strategic options. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Exploratory, post hoc and subgroup observations described in this release are hypothesis-generating and do not establish clinical efficacy or a causal explanation for the trial outcome. Readers should not place undue reliance on these statements. Diamyd Medical undertakes no obligation to update forward-looking statements except as required by applicable law or market rules. About Diamyd Medical Diamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The company’s investigational drug candidate retogatein, based on recombinant GAD65, was evaluated in the Phase 3 DIAGNODE-3 trial in recent-onset type 1 diabetes. The Company has established a facility for manufacturing of biological products in Umeå, Sweden. 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: Anders Essen-Möller, interim CEO Phone: +46 705 51 06 79 E-mail: anders.essen-moller@diamyd.com Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26 E-mail: info@diamyd.com Org. nr: 556242–3797 Website: https://www.diamyd.com The information was provided by the contact person above, for publication on 08.00 CET, July 27, 2026. Attachments: PDF version

临床3期临床结果免疫疗法

2026-06-24

·diamyd.com

Quarterly Report 3 25/26

September 2025 – May 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026 Diamyd manufacturing facility Diamyd Medical Diamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The Company has established a facility for manufacturing of biological products in Umeå, Sweden. 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. Further information is available on https://www.diamyd.com September 1, 2025 – May 31, 2026 Net sales: MSEK 0.4 (0.1), third quarter MSEK 0.1 (0.0) Net result: MSEK -238,8 (-124.9), third quarter MSEK -127.1 (-43.9) impacted by a provision corresponding to approximately 71 MSEK during the third quarter for close-down costs related to DIAGNODE-3 Result per share before and after dilution: SEK -0.8 (-1.2), third quarter: SEK -1.7 (-0.4) Cash flow from operating activities: MSEK -154.9 (-133.7), third quarter MSEK -71.7 (-43.5) Cash and short-term investments at May 31, 2026: MSEK 346.4 (319.3) Events during the third quarter Diamyd Medical announced that Niklas Axelsson has decided to leave his position as CFO Diamyd Medical received GMP certification and manufacturing authorization for biological investigational medicinal products for human use Diamyd Medical provided an update on strategic review and financial position Diamyd Medical strengthened its position in the manufacturing of biological medicines Diamyd Medical announced that Ulf Hannelius has decided to leave his position as CEO upon which Anders Essen-Möller has been reappointed to this position, and Erik Nerpin has been reappointed as Chairman of the Board Diamyd Medical discontinued DIAGNODE-3 following evaluation confirming futility and initiated strategic review Diamyd Medical provided updates on the interim efficacy analysis of Phase 3 DIAGNODE-3 trial Diamyd Medical reported negative interim results of Phase 3 DIAGNODE-3 trial Diamyd Medical entered into equity financing agreements with new U.S. sector specialist investors for up to USD 125 million and announced full enrolment in Phase 3 trial Diamyd Medical received Notice of Grant in Japan for insulin-based antigen therapy patent in type 1 diabetes Diamyd Medical finalized the database for interim analysis readout in DIAGNODE-3 trial Diamyd Medical announced the strengthening of its IP-position in the US Other events after the third quarter Diamyd Medical provided an update regarding Strategic Overview Diamyd Medical provided an update regarding interim CFO Diamyd Medical received Notice of Allowance for Key Precision Medicine Patent in the US Diamyd Medical provided an update on ongoing activities Comments by CEO Anders Essen-Möller Dear Shareholders, The past quarter has been one of the most challenging periods in Diamyd Medical’s history. Following the pre-specified interim analysis of our confirmatory Phase 3 trial DIAGNODE-3, we announced March 27, that the study yielded results that were totally unexpected and not aligned with prior retrospective or prospective data. Subsequent evaluation confirmed that the pre-specified futility criteria had been met, leading to the difficult but necessary decision to discontinue the trial. This result is deeply disappointing for everyone involved — especially for patients, investigators, study teams, employees and shareholders who have supported our mission over many years. Following review of data, randomization procedures and statistical assumptions, no factors have yet been identified that materially altered the interpretation of the interim results. Importantly, no new safety concerns were observed, and retogatein continued to demonstrate a favorable safety profile. The review of data is still ongoing. During the quarter, CEO Ulf Hannelius and CFO Niklas Axelsson decided to leave their positions and as a consequence, I was appointed to retake the position as CEO. Erik Nerpin – previously vice Chairman of the Board – was reappointed as Chairman of the Board. Most employees in the Stockholm office have been put on notice. Subsequent a provision of approximately 71 MSEK that has been made during the quarter related to close-down costs of the DIAGNODE-3 study, we expect our cost base to reduce and leave us with a cash position north of 200 MSEK by the end of this year, and with our Biomanufacturing unit in Umea remaining intact. Times are really tough currently. Whilst I do not wish anybody to go through what we currently are experiencing, I feel the need to step in as the CEO. At least for a short while. Yes, I am an old man. But with some experience. Let’s see how we can recover and regain shareholder value. In the meantime, please let me express my most sincere gratitude to all of us, unbelievable dedicated and amazing employees and shareholders. Following the outcome of the DIAGNODE-3 study, the Company’s immediate priority is to complete the close-out of the Phase 3 program in an efficient and responsible manner. Upon completion of this process, the Board intends to focus on evaluating opportunities to deploy the Company’s strong cash position in ways that can maximize long-term shareholder value. The Company will remain open to investments, partnerships, and strategic opportunities both within and outside the healthcare sector. At the same time, the Company will maintain its GMP-certified biomanufacturing facility in Umea and continue efforts to secure external interest from potential acquirers, customers, partners, and projects that can utilize the facility’s capabilities. The Company will also preserve and seek to maximize the value of its Precision Medicine platform and intellectual property portfolio in autoimmune diabetes. Future development activities related to GAD-based therapies will primarily be pursued together with external funding sources, including grants, collaborations, and strategic partnerships, with the goal of minimizing capital requirements while preserving potential upside. The Board believes this approach provides the greatest flexibility to preserve capital, evaluate new opportunities, and maximize value for shareholders. Again, I would like to express my sincere gratitude to our employees, investigators, study teams, collaborators, patients and shareholders for your continued support and dedication during this challenging period. Stockholm, June 24, 2026 Anders Essen-Möller, President and CEO *** The above is an excerpt from the report. To read the complete report, please visit https://www.diamyd.com, or see attached PDF *** About Diamyd Medical Diamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The Company has established a facility for manufacturing of biological products in Umeå, Sweden. 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. Further information is available on https://www.diamyd.com For more information, please contact: Anders Essen-Möller, President and CEO, anders.essen-moller@diamyd.com Diamyd Medical AB (publ), Box 7349, SE-103 90 Stockholm, Sweden Phone: +46 8 661 00 26 E-mail: info@diamyd.com Reg. no: 556242-3797 The information was submitted for publication, through the agency of the contact persons set out above, at 08.15 CET on June 24, 2026. Attachments: Quarterly Report 3 25/26

高管变更临床3期财报

2026-06-23

·diamyd.com

Diamyd Medical provides update on Strategic Review

Following the outcome of the DIAGNODE-3 study, the Company’s immediate priority is to complete the close-out of the Phase 3 program in an efficient and responsible manner. Upon completion of this process, the Board intends to focus on evaluating opportunities to deploy the Company’s strong cash position in ways that can maximize long-term shareholder value. The Company will remain open to investments, partnerships, and strategic opportunities both within and outside the healthcare sector. At the same time, the Company will maintain its GMP-certified biomanufacturing facility in Umea and continue efforts to secure external interest from potential acquirers, customers, partners, and projects that can utilize the facility’s capabilities. The Company will also preserve and seek to maximize the value of its Precision Medicine platform and intellectual property portfolio in autoimmune diabetes. Future development activities related to GAD-based therapies will primarily be pursued together with external funding sources, including grants, collaborations, and strategic partnerships, with the goal of minimizing capital requirements while preserving potential upside. The Board believes this approach provides the greatest flexibility to preserve capital, evaluate new opportunities, and maximize value for shareholders. “We are open for business,” says Anders Essen-Möller, Founder and CEO of Diamyd Medical. About Diamyd Medical Diamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The company’s investigational drug candidate retogatein, based on recombinant GAD65, was evaluated in the Phase 3 DIAGNODE-3 trial in recent-onset type 1 diabetes. The Company has established a facility for manufacturing of biological products in Umeå, Sweden. 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: Anders Essen-Möller, CEO Phone: +46 705 51 06 79 E-mail: anders.essen-moller@diamyd.com Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26 E-mail: info@diamyd.com Org. nr: 556242–3797 Website: https://www.diamyd.com The information was provided by the contact person above, for publication on 08.30 CET, June 23, 2026. Attachments: PDF version

临床3期

100 项与 Retogatein 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D13341	-	-	DB04963

研发状态

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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
成人隐匿性自身免疫性糖尿病	临床2期	瑞典	Diamyd Medical AB	2004-12-01

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临床结果

适应症

分期

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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


EASD2025	N/A	1型糖尿病	241	3-4 injections of rhGAD65	膚鹹衊顧繭鏇願觸艱鑰(鑰齋網願構鏇壓蓋醖衊) = 艱鏇蓋網醖襯壓醖繭憲選簾餘鬱鑰選蓋鬱窪齋 (夢憲簾鬱壓築蓋鬱選夢 ) 更多	积极	2025-09-15
EASD2025	N/A	1型糖尿病	241	2 injections of rhGAD65	膚鹹衊顧繭鏇願觸艱鑰(鬱範艱選糧鹹選範衊簾) = 衊艱廠齋蓋鹹壓積鹹觸衊鹽襯廠齋鬱齋製積廠 (網觸糧築廠顧憲膚鏇淵 )	积极	2025-09-15
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	範獵夢鏇獵窪壓鏇憲膚 = 築願製憲襯鹹憲顧襯獵簾夢願淵願艱築積構積 (築顧鑰醖醖夢鑰鬱憲襯, 憲選夢繭蓋艱醖觸窪範 ~ 憲觸網鬱製觸餘餘觸願) 更多	-	2025-06-08
NCT03345004 (DIAGNODE-2, CTgov)	临床2期	1型糖尿病	109	Vitamin D+Diamyd (Active Arm)	膚願鏇鑰獵齋衊鑰膚窪(醖鏇夢獵願蓋憲鏇蓋遞) = 構鬱獵繭積鏇壓觸獵遞遞積糧襯糧獵鹽願築窪 (夢範襯獵簾願積鬱壓夢, 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)	膚願鏇鑰獵齋衊鑰膚窪(醖鏇夢獵願蓋憲鏇蓋遞) = 鏇遞鹹範糧選顧鏇獵鑰遞積糧襯糧獵鹽願築窪 (夢範襯獵簾願積鬱壓夢, 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	遞壓壓膚鹽選鑰遞獵鹽 = 獵壓範鬱選鏇鬱積夢簾鹽鏇鏇壓淵餘膚顧鹹醖 (鏇艱廠顧鏇壓齋鬱構願, 願廠齋憲製顧築鹹遞膚 ~ 蓋壓遞選鬱鬱鏇窪鏇鏇) 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	鹽鏇製繭鏇繭獵窪膚範(鹹壓夢鑰願艱積壓醖膚) = 蓋夢淵廠衊網鹹鏇醖築構窪願壓觸獵憲願衊衊 (願齋蓋積餘鑰蓋憲壓蓋 ) 更多	积极	2019-12-20
NCT02464033 (CTgov)	临床2期	1型糖尿病	20	Vitamin D+Etanercept	觸齋夢遞積顧觸衊繭積 = 繭鹽選鏇觸範艱壓憲繭願鏇膚夢廠網鑰醖繭夢 (艱鏇網鏇選淵膚壓膚鑰, 積艱壓窪遞淵廠壓網襯 ~ 製獵簾繭齋夢範顧餘製) 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)	糧鏇繭製膚蓋艱夢遞艱 = 壓蓋窪壓衊鏇願廠鏇選淵願鹹網壓餘憲鹽淵製 (製構願鹽簾憲淵構繭襯, 憲醖憲淵憲獵餘衊膚衊 ~ 膚鏇觸遞鏇膚齋艱餘簾) 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))	糧鏇繭製膚蓋艱夢遞艱 = 廠願糧選觸構膚膚構網淵願鹹網壓餘憲鹽淵製 (製構願鹽簾憲淵構繭襯, 鬱醖糧醖築鹹範廠廠醖 ~ 製淵觸築憲淵餘簾衊製) 更多	-	2019-05-06
NCT00529399 (TN08, CTgov)	临床2期	1型糖尿病	145	GAD-Alum (GAD-alum)	鬱壓蓋憲遞窪蓋憲築醖(簾鏇窪鹹襯觸範繭積襯) = 構願構獵膚遞衊積膚窪鏇繭窪願蓋製壓窪膚糧 (繭顧壓膚鑰鏇窪鹹觸鹽, 壓顧鬱顧製襯製膚壓積 ~ 選糧積艱鏇鬱積鑰選衊) 更多	-	2016-12-07
NCT00529399 (TN08, CTgov)	临床2期	1型糖尿病	145	Alum (GAD-alum Plus Alum)	鬱壓蓋憲遞窪蓋憲築醖(簾鏇窪鹹襯觸範繭積襯) = 鏇齋蓋憲窪壓鬱壓蓋顧鏇繭窪願蓋製壓窪膚糧 (繭顧壓膚鑰鏇窪鹹觸鹽, 夢蓋窪鏇繭範窪夢淵鬱 ~ 膚窪鑰壓艱製選鏇艱艱) 更多	-	2016-12-07
NCT00837759 (CTgov)	临床2期	1型糖尿病	7	Insulin+Sitagliptin+Lansoprazole+GAD65	鬱膚觸選鏇醖獵網範衊(網鹽積遞簾積憲鬱鹽簾) = 膚襯顧夢淵鹹積醖網襯壓鹹窪範顧餘鹽憲網齋 (膚遞夢範蓋膚觸願糧膚, 0.53) 更多	-	2012-10-24