A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
NCT ID: NCT05018585
Last Updated: 2026-01-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
330 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-19
Study Completion Date
2027-12-31
Brief Summary
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The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd 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.
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Detailed Description
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The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients will have the HLA genotyping performed at the first Screening visit (Visit 1A). If the results indicate the patient is carrying the HLA DR3-DQ2 haplotype, then the patient will attend the second Screening visit (Visit 1B) to perform the remaining screening procedures. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals along with oral Vitamin D supplementation. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. Patients will be followed in a blinded manner for a total of 24 months.
Conditions
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Type 1 Diabetes Mellitus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Diamyd
Patients will be assigned to receive i) three (3) intralymphatic injections with 4µg Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
Group Type
EXPERIMENTAL
Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
Intervention Type
BIOLOGICAL
Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
Colecalciferol 2000 IU
Intervention Type
DIETARY_SUPPLEMENT
Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
Placebo
Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)
Group Type
PLACEBO_COMPARATOR
Colecalciferol 2000 IU
Intervention Type
DIETARY_SUPPLEMENT
Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
Placebo
Intervention Type
BIOLOGICAL
Placebo for Diamyd, Alhydrogel® only
Interventions
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Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
Intervention Type
BIOLOGICAL
Colecalciferol 2000 IU
Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
Intervention Type
DIETARY_SUPPLEMENT
Placebo
Placebo for Diamyd, Alhydrogel® only
Intervention Type
BIOLOGICAL
Other Intervention Names
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Diamyd
Divisun 2000 IU
Eligibility Criteria
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Inclusion Criteria
Patients are eligible to be included in this study only if all of the following criteria apply:
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.
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 prior to randomization.
(US ONLY): Fasting C-peptide ≥0.12 - ≤1.5 nmol/L (≥0.36 - ≤4.5 ng/mL) on at least one occasion prior to randomization.
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 basal insulin dose for one month prior to inclusion with limited fluctuation of daily basal insulin requirement based on investigator's assessment. For example, if the average basal insulin dose/kg/24h over a 7-day period compared to the previous 7-day period does not vary more than approximately 20% and/or if the daily basal 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:
* Oral.
* Intravaginal.
* Transdermal.
* Progestogen-only hormonal contraception associated with inhibition of ovulation:
* Oral.
* Injectable.
* 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 informed consent; the patient or legally authorized representatives (e.g., parents, caregivers, or legal guardians) must sign this specific section.
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.
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 prior to randomization.
(US ONLY): Fasting C-peptide ≥0.12 - ≤1.5 nmol/L (≥0.36 - ≤4.5 ng/mL) on at least one occasion prior to randomization.
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 basal insulin dose for one month prior to inclusion with limited fluctuation of daily basal insulin requirement based on investigator's assessment. For example, if the average basal insulin dose/kg/24h over a 7-day period compared to the previous 7-day period does not vary more than approximately 20% and/or if the daily basal 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:
* Oral.
* Intravaginal.
* Transdermal.
* Progestogen-only hormonal contraception associated with inhibition of ovulation:
* Oral.
* Injectable.
* 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 informed consent; the patient or legally authorized representatives (e.g., parents, caregivers, or legal guardians) must sign this specific section.
Exclusion Criteria
Patients are not eligible to be included in this study if any of the following criteria apply:
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 or other substance used with the intention to preserve beta cell function (e.g., Verapamil, GABA etc.) 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 (e.g., pancreatogenous diabetes).
5. Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization (Visit 2).
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:
1. Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis.
2. 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 visit.
3. Significant iron deficiency anemia.
4. Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes.
8. (US ONLY) Clinically significant abnormal hematology results at the time of Screening, specifically any of the following: white blood cells: \< 3.5 x 109/L or \>15 x 109/L; platelets: \<124 x 109/ L hemoglobin: \<10.5 g/dL
9. 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 trial-provided Vitamin D. A patient currently taking Vitamin D at the time of Screening (V1C) must be willing to switch to the trial-provided Vitamin D treatment and to administer it per the trial requirements.
10. (US ONLY) History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
11. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel).
12. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first trial dose of trial drug; or planned treatment with any vaccine up to 4 weeks after the last injection with trial drug.
13. Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
14. Recent (past 12 months) or current treatment with Teplizumab (TZIELD®) or with immunosuppressant therapy, including chronic use of systemic glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral, intra-articular injections or injections of steroids will be permitted during the trial.
15. 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.
16. Known or suspected acute infection, including COVID-19 or influenza, at the time of Randomization or within 4 weeks prior to Randomization.
17. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
18. 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.
19. 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 opinion of the investigator would interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion.
(US ONLY) Any clinically significant concomitant medical condition, including but not limited to other autoimmune or immune deficiency diseases (e.g., sarcoidosis, rheumatoid arthritis, moderate-to-severe psoriasis, inflammatory bowel disease, and other autoimmune conditions that may require treatment with TNF-alpha inhibitors or other biologics), gastrointestinal, hematological, or renal diseases including a history of any organ transplant (including renal transplantation and islet transplantation), neurological disease (including Batten disease); significant diabetes complication; a history of adrenal insufficiency; any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion, as well as autoimmune thyroid disease under certain conditions (see Exclusion Criterion #23).
20. (US ONLY) Significant cardiovascular disease (including inadequately controlled hypertension \[resting blood pressure \>140/90 mmHg despite treatment\], history of myocardial infarction, angina, use of anti-anginal medicines \[e.g., nitroglycerin\], or abnormal cardiac stress test.
21. History of significant hepatic disease or Screening alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) or aspartate aminotransferase (AST) 3 x ULN and/or total bilirubin \>2 x ULN. Patients with documented Gilbert syndrome and total bilirubin level ≥2 x ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
22. Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) for those \>18 years, or by the Schwartz equation for those 12 to 18 years old, \<60 mL/min per 1.73 m or rapidly progressing renal disease.
23. Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine \[T4\] levels if hypothyroid).
(US ONLY) Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine \[T4\] levels if hypothyroid). A thyroid-stimulating hormone (TSH) level \> 1.5 times the ULN at Screening (V1B) is an exclusion criterion.
24. Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial.
(US ONLY) Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial. This includes anticipated major surgery during the duration of the trial, which could interfere with participation in the trial.
25. History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
26. Patients with any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the trial, and/or evidence of poor compliance with medical instructions at Screening or showing non-compliance during the Run-In Period.
27. A history of alcohol or drug abuse or dependence within the past 12 months based on DSM IV criteria.
28. Previous treatment with the active substance recombinant human GAD65.
29. Participation in a clinical trial involving administration of an investigational drug in the past 3 months or 5 half-lives (whichever is longer) prior to first dosing of trial drug or during the trial.
30. Females who are breastfeeding, pregnant or plan to become pregnant during the trial.
31. Patients who in the opinion of the investigator will not be able to follow instructions and/or follow the trial procedures or patients that are unwilling or unable to comply with the provisions of this protocol.
32. An employee or immediate family member of an employee of Diamyd Medical AB.
33. (US ONLY)For subjects aged 18 years and older, a body mass index (BMI) ≥30 kg/m2 or ≤18.5 kg/m2; for subjects aged under 18 years BMI ≥95th percentile or ≤5th percentile for age and sex according to the US Centre for Disease Control and Prevention at V1B. (For subjects aged 18 years and older with a BMI ≥25 to ≤30 kg/m2, and for subjects aged under 18 years with a BMI ≥85th to ≤95th percentile, re-confirmation of Type 1 Diabetes diagnoses by an external, independent endocrinologist is required prior to randomization.)
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 or other substance used with the intention to preserve beta cell function (e.g., Verapamil, GABA etc.) 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 (e.g., pancreatogenous diabetes).
5. Occurrence of DKA or severe hypoglycemia requiring hospitalization in the period of 90 days prior to Randomization (Visit 2).
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:
1. Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis.
2. 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 visit.
3. Significant iron deficiency anemia.
4. Heart malformations or vaso-occlusive crisis (VOC) leading to increased turnover of erythrocytes.
8. (US ONLY) Clinically significant abnormal hematology results at the time of Screening, specifically any of the following: white blood cells: \< 3.5 x 109/L or \>15 x 109/L; platelets: \<124 x 109/ L hemoglobin: \<10.5 g/dL
9. 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 trial-provided Vitamin D. A patient currently taking Vitamin D at the time of Screening (V1C) must be willing to switch to the trial-provided Vitamin D treatment and to administer it per the trial requirements.
10. (US ONLY) History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
11. Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel).
12. Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first trial dose of trial drug; or planned treatment with any vaccine up to 4 weeks after the last injection with trial drug.
13. Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
14. Recent (past 12 months) or current treatment with Teplizumab (TZIELD®) or with immunosuppressant therapy, including chronic use of systemic glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral, intra-articular injections or injections of steroids will be permitted during the trial.
15. 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.
16. Known or suspected acute infection, including COVID-19 or influenza, at the time of Randomization or within 4 weeks prior to Randomization.
17. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles.
18. 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.
19. 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 opinion of the investigator would interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion.
(US ONLY) Any clinically significant concomitant medical condition, including but not limited to other autoimmune or immune deficiency diseases (e.g., sarcoidosis, rheumatoid arthritis, moderate-to-severe psoriasis, inflammatory bowel disease, and other autoimmune conditions that may require treatment with TNF-alpha inhibitors or other biologics), gastrointestinal, hematological, or renal diseases including a history of any organ transplant (including renal transplantation and islet transplantation), neurological disease (including Batten disease); significant diabetes complication; a history of adrenal insufficiency; any underlying conditions or receiving treatments that could affect red blood cell turnover or other diseases that interfere with trial participation or procedures. Celiac disease or elevated transglutaminase antibody titers is not a reason for exclusion, as well as autoimmune thyroid disease under certain conditions (see Exclusion Criterion #23).
20. (US ONLY) Significant cardiovascular disease (including inadequately controlled hypertension \[resting blood pressure \>140/90 mmHg despite treatment\], history of myocardial infarction, angina, use of anti-anginal medicines \[e.g., nitroglycerin\], or abnormal cardiac stress test.
21. History of significant hepatic disease or Screening alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) or aspartate aminotransferase (AST) 3 x ULN and/or total bilirubin \>2 x ULN. Patients with documented Gilbert syndrome and total bilirubin level ≥2 x ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
22. Estimated glomerular filtration rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) for those \>18 years, or by the Schwartz equation for those 12 to 18 years old, \<60 mL/min per 1.73 m or rapidly progressing renal disease.
23. Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine \[T4\] levels if hypothyroid).
(US ONLY) Patients diagnosed with hypothyroidism or hyperthyroidism must be on stable treatment for at least 3 months prior to Randomization (with normal free thyroxine \[T4\] levels if hypothyroid). A thyroid-stimulating hormone (TSH) level \> 1.5 times the ULN at Screening (V1B) is an exclusion criterion.
24. Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial.
(US ONLY) Any clinically significant abnormal findings during Screening, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or ability to complete the trial. This includes anticipated major surgery during the duration of the trial, which could interfere with participation in the trial.
25. History of malignancy not in remission within the last 5 years other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
26. Patients with any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the trial, and/or evidence of poor compliance with medical instructions at Screening or showing non-compliance during the Run-In Period.
27. A history of alcohol or drug abuse or dependence within the past 12 months based on DSM IV criteria.
28. Previous treatment with the active substance recombinant human GAD65.
29. Participation in a clinical trial involving administration of an investigational drug in the past 3 months or 5 half-lives (whichever is longer) prior to first dosing of trial drug or during the trial.
30. Females who are breastfeeding, pregnant or plan to become pregnant during the trial.
31. Patients who in the opinion of the investigator will not be able to follow instructions and/or follow the trial procedures or patients that are unwilling or unable to comply with the provisions of this protocol.
32. An employee or immediate family member of an employee of Diamyd Medical AB.
33. (US ONLY)For subjects aged 18 years and older, a body mass index (BMI) ≥30 kg/m2 or ≤18.5 kg/m2; for subjects aged under 18 years BMI ≥95th percentile or ≤5th percentile for age and sex according to the US Centre for Disease Control and Prevention at V1B. (For subjects aged 18 years and older with a BMI ≥25 to ≤30 kg/m2, and for subjects aged under 18 years with a BMI ≥85th to ≤95th percentile, re-confirmation of Type 1 Diabetes diagnoses by an external, independent endocrinologist is required prior to randomization.)
Minimum Eligible Age
12 Years
Maximum Eligible Age
28 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Diamyd Medical AB
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Johnny Ludvigsson, Professor
Role: PRINCIPAL_INVESTIGATOR
Crown Princess Victoria Children´s Hospital and Linköping University
Locations
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Mary and Dick Allen Diabetes Center at Hoag Hospital
Newport Beach, California, United States
Site Status
Stanford University School of Medicine Center for Academic Medicine
Palo Alto, California, United States
Site Status
UCSD/ Rady Children's Hospital
San Diego, California, United States
Site Status
University of Colorado Anschutz Medical Campus, Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Site Status
Diabetes Research Institute (DRI)-University of Miami Leonard M. Miller School of Medicine (UMMSM)
Miami, Florida, United States
Site Status
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Site Status
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Site Status
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
Joslin Diabetes Center
Boston, Massachusetts, United States
Site Status
Washington University Diabetes Center at Barnes Jewish Hospital
St Louis, Missouri, United States
Site Status
Hassenfeld Children's Hospital at NYU Langone Health, Pediatric Diabetes Center
New York, New York, United States
Site Status
Amarillo Medical Specialists
Amarillo, Texas, United States
Site Status
Diabetes & Glandular Disease Clinic
San Antonio, Texas, United States
Site Status
Nemocnice Jihlava, příspěvková organizace
Jihlava, , Czechia
Site Status
Institut klinické a experimentální medicíny
Prague, , Czechia
Site Status
Fakultní nemocnice v Motole
Prague, , Czechia
Site Status
Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, , Czechia
Site Status
Liina Viitas OÜ
Pärnu, , Estonia
Site Status
North-Estonian Regional Hospital
Tallinn, , Estonia
Site Status
Tartu University Hospital
Tartu, , Estonia
Site Status
Tartu University Hospital, Children's Clinic
Tartu, , Estonia
Site Status
Diabetespraxis Dr. Braun
Berlin, , Germany
Site Status
Diabetologische Schwerpunktpraxis Dres. Klaus
Dortmund, , Germany
Site Status
DZDM - Diabeteszentrum Duisburg Mitte
Duisburg, , Germany
Site Status
Justus-Liebig-Universität Gießen
Giessen, , Germany
Site Status
Óbudai Egészségügyi Centrum
Budapest, , Hungary
Site Status
Heim Pál Országos Gyermekgyógyászati Intézet, Diabetológia
Budapest, , Hungary
Site Status
Észak-Budai Szent János Centrumkórház, Kútvölgyi Kórház, Belgyógyászat
Budapest, , Hungary
Site Status
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi, Oktatókórház, Jósa András Oktatókórház, Gyermekosztály
Nyíregyháza, , Hungary
Site Status
Markusovszky Egyetemi Oktatókórház, Diabetológiai Szakrendelés
Szombathely, , Hungary
Site Status
CTU Vasculaire Geneeskunde, Locatie Academic Medical Center (AMC)
Amsterdam, , Netherlands
Site Status
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Site Status
Bethesda Diabetes Research Center te Hoogeveen
Hoogeveen, , Netherlands
Site Status
Dept. of Nephrology / Dept. of Endocrinology, Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Site Status
Vivendia
Nijmegen, , Netherlands
Site Status
Diabeter Nederland te Rotterdam
Rotterdam, , Netherlands
Site Status
Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku, Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii
Bialystok, , Poland
Site Status
Uniwersyteckie Centrum Kliniczne, Klinika Pediatrii, Diabetologii i Endokrynologii
Gdansk, , Poland
Site Status
SP ZOZ Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Chorób Metabolicznych i Diabetologii
Krakow, , Poland
Site Status
NZOZ Przychodnia Specjalistyczna Medica
Lublin, , Poland
Site Status
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie, II Klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej
Rzeszów, , Poland
Site Status
Instytut Diabetologii Sp. z o.o
Warsaw, , Poland
Site Status
Panstwowy Instytut Medyczny MSWiA Klinika Chorob Wewnetrznych, Endokrynologii i Diabetologii
Warsaw, , Poland
Site Status
Instytut Pomnik - Centrum Zdrowia Dziecka (IPCZD) Oddział Diabetologii
Warsaw, , Poland
Site Status
Hospital De Cruces
Barakaldo, , Spain
Site Status
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Site Status
Hospital Clínic de Barcelona
Barcelona, , Spain
Site Status
Hospital de Sant Joan de Déu - Esplugues De Llobregat, Barcelona
Barcelona, , Spain
Site Status
Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Site Status
Complejo Hospitalario Insular de Gran Canaria
Las Palmas, , Spain
Site Status
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Site Status
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Site Status
Hospital Universitario La Paz
Madrid, , Spain
Site Status
Hospital Regional Universitario de Málaga
Málaga, , Spain
Site Status
Hospital Universitario Virgen Macarena
Seville, , Spain
Site Status
Hospital General Universitario de Valencia
Valencia, , Spain
Site Status
Skånes universitetssjukhus
Malmo, Skåne County, Sweden
Site Status
Akademiskt Specialistcentrum, Centrum for Diabetes
Stockholm, Stockholm County, Sweden
Site Status
Barn-och Ungdomscentrum Västerbotten, Norrlands Universitetssjukhus
Umeå, Västerbotten County, Sweden
Site Status
H.K.H Kronprinsessan Victorias Barn-och Ungdomssjukhus, Universitetssjukhuset i Linköping
Linköping, Östergötland County, Sweden
Site Status
Countries
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United States
Czechia
Estonia
Germany
Hungary
Netherlands
Poland
Spain
Sweden
References
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Ludvigsson J, Eriksson L, Nowak C, Teixeira PF, Widman M, Lindqvist A, Casas R, Lind M, Hannelius U. 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. BMJ Open. 2022 Oct 31;12(10):e061776. doi: 10.1136/bmjopen-2022-061776.
Reference Type
DERIVED
Related Links
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https://diagnode-3.com/
Study website
Other Identifiers
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2024-513304-33-00
Identifier Type: CTIS
Identifier Source: secondary_id
DIAGNODE-3 (D/P3/21/7)
Identifier Type: -
Identifier Source: org_study_id
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