Study on the Safety and Effectiveness of Diamyd and Colecalciferol for Adolescents and Adults with Recently Diagnosed Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying Type 1 Diabetes, a condition where the body’s immune system attacks the cells in the pancreas that produce insulin. The study aims to evaluate the safety and effectiveness of a treatment called Diamyd, which is a suspension for injection containing a substance known as glutamate decarboxylase 2, human, recombinant. This treatment is being tested to see if it can help preserve the function of the insulin-producing cells in people who have recently been diagnosed with Type 1 Diabetes and carry a specific genetic marker known as the HLA DR3-DQ2 haplotype. Some participants in the study may receive a placebo instead of the actual treatment.

The study will involve participants receiving three doses of Diamyd over a period of time, with the goal of assessing its impact on the body’s ability to produce insulin and maintain blood sugar levels. Participants will be monitored for changes in their insulin production and blood sugar control over the course of the study. The study will also look at the safety of the treatment by tracking any side effects or reactions that occur during the trial.

In addition to Diamyd, the study will also involve the use of Divisun 2000 IE tabletter, which contains colecalciferol, commonly known as Vitamin D3. This is a vitamin supplement taken orally in tablet form. The study will last for a period of up to 24 months, during which participants will undergo regular assessments to monitor their health and the effects of the treatment. The overall aim is to determine if Diamyd can help preserve the body’s natural insulin production in people with newly diagnosed Type 1 Diabetes.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, recent diagnosis of type 1 diabetes, and specific genetic markers.

Blood tests are performed to check for the presence of certain antibodies and to measure C-peptide and HbA1c levels.

2 randomization

Participants are randomly assigned to receive either the investigational drug Diamyd or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

The investigational drug Diamyd is administered as a suspension for injection through intralymphatic use. The treatment consists of three doses.

Participants also receive Divisun tablets, containing colecalciferol, taken orally. The dosage is 2000 IE per tablet.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor health and response to treatment. This includes physical examinations, blood tests, and continuous glucose monitoring.

Participants are observed for any adverse effects, including injection site reactions and changes in vital signs.

5 final evaluation

At the end of the 24-month period, a final evaluation is conducted to assess changes in C-peptide levels and HbA1c, as well as overall health outcomes.

The study aims to determine the efficacy of Diamyd in preserving insulin production and secretion.

Who Can Join the Study?

  • Must be able to provide written, signed, and dated informed consent. For minors, age-appropriate agreement and parent or caregiver consent are required.
  • Must be between 12 and 28 years old at the time of screening. In Germany, only those aged 18 to 28 will be enrolled.
  • Must have been diagnosed with Type 1 diabetes (T1D) within the last 6 months. T1D is a condition where the body does not produce insulin.
  • Must have a specific genetic marker called HLA DR3-DQ2 haplotype. This will be tested during the study.
  • Must have a fasting C-peptide level of at least 0.12 nmol/L. C-peptide is a substance made in the pancreas, and its level helps to understand how much insulin the body is producing.
  • Must have detectable GAD65 antibodies. These are proteins made by the immune system that can attack the body’s own cells.
  • Must have HbA1c levels between 35 to 80 mmol/mol (5.4 to 9.5%). HbA1c is a measure of blood sugar levels over the past 2 to 3 months.
  • Must be on a stable insulin basal dose for one month before joining the study. This means the daily insulin dose should not change much.
  • Females who can have children must agree to avoid pregnancy and have a negative pregnancy test during the study. They must use highly effective birth control methods during treatment and for 90 days after the last dose.
  • Males must agree to avoid fathering a child during treatment and for 90 days after. If sexually active, they must use two effective birth control methods.

Who Cannot Join the Study?

  • Individuals who do not have Type 1 diabetes mellitus. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Individuals who do not carry the HLA DR3-DQ2 haplotype. This is a specific genetic marker that some people with Type 1 diabetes have.
  • Individuals who do not have antibodies against GAD65. These are proteins made by the immune system that mistakenly attack parts of the body, in this case, related to diabetes.
  • Individuals who carry the HLA DR4-DQ8 haplotype. This is another genetic marker that is not included in this study.
  • Individuals who are not adolescents or adults. The study is focused on these age groups.
  • Individuals who are not recently diagnosed with Type 1 diabetes. The study is for those who have been diagnosed recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie Rzeszow Poland
Diabetespraxis Dr. Braun Berlin Germany

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Region Vaesterbotten Umea Sweden
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Region Stockholm – SLSO Stockholm Sweden
Instytut Diabetologii Sp. z o.o. Warsaw Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Region Skane Skanes Universitetssjukhus Lund Sweden
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Eszak-Budai Szent Janos Centrumkorhaz Budapest Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR Dortmund Germany
NZOZ Medica Lublin Poland
Hospital Clinic De Barcelona Barcelona Spain
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Tartu University Hospital Tartu Estonia
Hospital Universitario De Cruces Barakaldo Spain
Hospital General Universitario De Valencia Valencia Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej Bialystok Poland
Krajska zdravotni a.s. Teplice Czechia
North Estonia Medical Centre Foundation Tallin Estonia
Heim Pal Orszagos Gyermekgyogyaszati Intezet Budapest Hungary
Irrrlsxwf Fjs Cgioabtm Arb Ebujpytufcpd Mkymjgrn Prague Czechia
Lfykw Utjnamguldqa Mbfgpsy Cyejtpq (vciwz Leiden The Netherlands
Dosalmgq Nqywxseep Bocb Rotterdam The Netherlands
Damagsuwlzwljdi Diatfoce Mzsnf Duisburg Germany
Frshlwzl nnowfrtoi Mrpek a Hyamqns Prague Czechia
Atfnejztq Uzk Amsterdam The Netherlands
Pjyqhbpnm Izrxfukc Moenjjjr Mdcsajdpqgbk Sjcmc Wpmcklxozwtj I Awbkykhbmurmv Warsaw Poland
Uxzunjvmfdwtyf Cdcebpm Kzfkesxmt Gdansk Poland
Fskezkftv Pfma Ld Ihsofbvgnhjdz Bwvikwdja Dwt Hivhawkl Uwedicorxcyyh Lk Pov Madrid Spain
Lberq Vbowqi Om Paernu Estonia
Hrolsknj Vbvz dwopklhr Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
17.03.2022
Estonia Estonia
Not recruiting
17.03.2022
Germany Germany
Not recruiting
17.03.2022
Hungary Hungary
Not recruiting
17.03.2022
Poland Poland
Not recruiting
17.03.2022
Spain Spain
Not recruiting
17.03.2022
Sweden Sweden
Not recruiting
17.03.2022
The Netherlands The Netherlands
Not recruiting
17.03.2022

Trial locations

Diamyd is a medication being studied to see if it can help preserve the function of beta cells in the pancreas. Beta cells are important because they produce insulin, which helps control blood sugar levels. This medication is being tested in people who have recently been diagnosed with Type 1 Diabetes and have a specific genetic marker called HLA DR3-DQ2. The goal is to see if Diamyd can help maintain the body’s ability to produce insulin naturally and improve blood sugar control.

Type 1 diabetes mellitus – This is an autoimmune disease where the body’s immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. As a result, the body produces little or no insulin, a hormone necessary for glucose to enter cells and produce energy. The disease often begins in childhood or adolescence but can develop in adults. Symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression involves a gradual decline in insulin production, requiring lifelong management to maintain normal blood sugar levels.

Trial ID:
2024-513304-33-00
Protocol code:
DIAGNODE-3
NCT ID:
NCT05018585
Trial Phase:
Therapeutic confirmatory (Phase III)

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