EUCTR2021-002731-32-EE招募中1 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 - DIAGNODE-3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Must be capable of providing written, signed, and dated informed consent; and for patients who are minors, age-appropriate assent (performed according to local regulations) and parent/caregiver consent.
- •2. Males and females aged =12 and <29 years old at the time of Screening(V1A) .
- •Note: In Germany only male and female adults (18 to <29 years of age) will be enrolled.
- •3. Diagnosed with T1D (according to the American Diabetes Association [ADA] classification) =6 months at the time of Screening(V1A).
- •4. Possess the HLA DR3-DQ2 haplotype (all patients will be tested; prior genetic testing results will not be accepted).
- •5. Fasting C-peptide =0.12 nmol/L (=0.36 ng/mL) on at least one occasion.
- •6. Possess detectable circulating GAD65 antibodies (lowest level of detection defined by the method used by the central laboratory).
- •7. Possess HbA1c levels between 35 to 80 mmol/mol (5.4 to 9.5%) on at least one occasion prior to randomization.
- •8. Be on a stable insulin dose or insulin dosing regimen for one month prior to inclusion with limited fluctuation of daily insulin requirement based on investigator’s assessment. For example, if the average insulin dose/kg/24h over a 7-day period compared to the previous 7day period does not vary more than
- •approximately 15% and/or if the daily insulin dose does not vary more than 0.1 U/kg/24h, the dose can be considered stable. Individuals that are diagnosed with T1D according to the ADA classification but are not taking insulin are eligible to participate.
- •9. (i). Females of childbearing potential (FOCBP) must agree to avoid pregnancy and have a negative pregnancy test performed at the required study visits.
- •FOCBP must agree to use highly effective contraception, during treatment and, until 90 days after the last administration of study medication. Birth control methods, which may be considered as highly effective (e.g., a failure rate of less than 1% per year when used consistently and correctly) include:
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •o Intravaginal.
- •o Transdermal.
- •Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •o Injectable.
- •o Implantable.
- •Intrauterine device.
- •Intrauterine hormone-releasing system.
- •Bilateral tubal occlusion.
- •Vasectomized partner (vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the FOCBP trial patient and that the vasectomized partner has received medical assessment of the surgical success).
- •Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient).
- •9. (ii). Male patients must agree to remain abstinent from heterosexual sex during treatment and for 90 days after treatment or, if sexually active, to use two effective methods of birth control (e.g., male uses a condom and female uses contraception) during and for 90 days after treatment. Acceptable male contraception is as follows:
- •Condom (male).
- •Abstinence from heterosexual intercourse.
- •Vasectomy.
- •The agreement to remain abstinent or use two effective methods of birth control will be clearly defined in the inf
排除标准
- •1. Participation in any other trial aimed to influence beta cell function from time of diagnosis of T1D.
- •2. Treatment with any oral or non-insulin injectable anti-diabetic medication within 3 months prior to Randomization.
- •3. History of maturity-onset diabetes of the young (MODY).
- •4. Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased beta cell capacity.
- •5. Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization.
- •6. Signs or symptoms suggesting very poorly controlled diabetes e.g., ongoing weight loss, polyuria or polydipsia.
- •7. Hematologic condition that would make HbA1c uninterpretable including:
- •a) Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis.
- •b) Donation of blood or blood products to a blood bank, blood transfusion or participation in a clinical study requiring withdrawal of >400 mL of blood during the 8 weeks prior to the Screening (V1B) visit.
- •c) Significant iron deficiency anemia.
- •d) Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes.
- •8. Treatment with marketed or over-the-counter Vitamin D at the time of Screening (V1C) and unwilling to abstain from such medication during the 120 days when the patient will be supplemented with the study-provided Vitamin D. A patient currently taking Vitamin D at the time of Screening (V1C) must be willing to switch to the study-provided Vitamin D treatment and to administer it per the study requirements.
- •9. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel).
- •10. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first study dose of study drug; or planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
- •11. Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
- •12. Recent (past 12 months) or current treatment with immunosuppressant therapy, including chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., =5 days) of oral or intra-articular injections of steroids will be permitted on trial.
- •13. Continuous/chronic treatment with prescribed or over-the-counter anti-inflammatory therapies. Short-term use (e.g., <7 days) is permissible, for example to treat a headache or in connection with a fever.
- •14. Known or suspected acute infection, including COVID-19 or influenza, at the time of Randomization or within 4 weeks prior to Randomization.
- •15. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
- •16. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients with previous hepatitis C infection that is now cured may be eligible.
- •17. Any clinically significant concomitant medical condition, including but not limited to other autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a history of renal transplantation, neurological (including Batten disease), significant diabetes complication, any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that in the
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