Diabetes Mellitus, Type 1Phase 2NCT03345004
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
A Phase 2 study testing Diamyd and Vitamin D in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Diamyd Medical AB at 18 sites in 4 countries.
Trial summary
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases
- What is being tested?
- Diamyd and Vitamin D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 20 Dec 2017to 27 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
- Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA) classification diagnosed ≤6 months at the time of screening
- Age: ≥12 and <25 years old
- Fasting C-peptide ≥0.12 nmol/L (0.36 ng/ml) on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
- Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but < 50 000 IU/ml
- Females must agree to avoid pregnancy and have a negative urine pregnancy test. Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. Adequate contraception is as follows:
Show all 19Show fewer
- For females of childbearing potential:
- oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- combined (estrogen and progestogen containing)
- oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
- intrauterine device
- intrauterine hormone-releasing system (for example, progestin-releasing coil)
- bilateral tubal occlusion
- vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- male partner using condom
- abstinence from heterosexual intercourse
- For males of childbearing potential:
- condom (male)
- abstinence from heterosexual intercourse
Who cannot join
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Treatment with any oral or injected anti-diabetic medications other than insulin
- A history of anemia or significantly abnormal hematology results at screening
- A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- Clinically significant history of acute reaction to vaccines or other drugs in the past
Show all 15Show fewer
- Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- Inability or unwillingness to comply with the provisions of this protocol
- A history of alcohol or drug abuse
- A significant illness other than diabetes within 2 weeks prior to first dosing
- Known HIV or hepatitis
- Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd/placebo treatment)
- Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Spain9 sites
Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces
Barakaldo, 48903
Adult Endocrinology and Diabetology, Hospital vall D' Hebrón
Barcelona, 08035
Pediatrics Endocrinology and Diabetology, Hospital Vall D'Hebrón
Barcelona, 08035
Adult Endocrinology and Diabetology, Hospital Ramón y Cajal
Madrid, 28033
Adult Endocrinology and Diabetology, Hospital Carlos Haya
Málaga, 29009
Pediatrics Endocrinology and Diabetology, Hospital Materno-Ifantil
Málaga, 29011
Adult Endocrinology and Diabetology, Hospital Macarena
Seville, 41009
Pediatrics Endocrinology and Diabetology, Hospital Virgen del Rocío
Seville, 41013
Adult and Pediatrics Endocrinology and Diabetology, Hospital Miguel Servet
Zaragoza, 50009
Sweden6 sites
Barn- och Ungdomskliniken, Universitetssjukhuset
Linköping, 58185
Endokrinmedicinska kliniken. Universitetssjukhuset
Linköping, 58185
Barn-och Ungdomsmedicinmottagningen and Endokrinmottagningen, Skånes Universitetssjukhus
Malmö, 20502
Barn- och ungdomskliniken, Uddevalla Sjukhus
Uddevalla, 45180
Diabetesmottagningen, Uddevalla Sjukhus
Uddevalla, 45180
Barnmottagningen, Norrlands Universitetssjukhus
Umeå, 901 85
Czechia2 sites
Diabetes Centre, Institute of Clinical and Experimental Medicine
Prague, 14021
Department of Paediatrics, University Hospital Motol
Prague, 15006
About this study
Official title: A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
Read the detailed description
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. The patients will be followed in a blinded manner for a total of 15 months. All patients that have not performed the 15 months visit when the updated protocol is implemented, will be asked to participate in the Extension Study Period which includes an additional visit at month 24.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases, Metabolic Disease, Glucose Metabolism Disorders, Immune System Diseases
- Being tested
- Diamyd, Vitamin D, Placebo for Diamyd, Placebo for Vitamin D
- Keywords
- Diamyd, Diabetes, Juvenile Diabetes, Diabetes Type 1, Type 1 Diabetes, Autoimmune Diabetes, Insulin Dependent Diabetes, Type 1 Diabetes Mellitus, rhGAD65, GAD65, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D, Vitamins, Micronutrients, Cholecalciferol, Ergocalciferols
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases, Metabolic Diseases, Glucose Metabolism Disorders, Immune System Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiamydBiological
Also called GAD-alum
Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)
Vitamin DDietary supplement
Oil suspension of Vitamin D
Placebo for DiamydBiological
Alhydrogel® only
Placebo for Vitamin DDietary supplement
Placebo oil suspension for Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Patients will be assigned to receive i) three (3) intralymphatic injections with Recombinant human Glutamic Acid Decarboxylase adsorbed to Alhydrogel (Diamyd) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) Receives: Biological: Diamyd; Dietary Supplement: Vitamin D |
| Placebo arm | Placebo comparator | Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) Receives: Biological: Placebo for Diamyd; Dietary Supplement: Placebo for Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stimulated C-peptide During a MMTT
Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve [AUC] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.
Measured: Baseline and 15 months
Secondary outcomes (20)
Change in IDAA1c
Change in insulin-dose-adjusted HbA1c (IDAA1c)
Measured: Baseline and 15 months
Change in HbA1c
Change in HbA1c (mmol/mol)
Measured: Baseline and 15 months
Change in Insulin Consumption
Change in daily exogenous insulin consumption (IU)
Measured: Baseline and 15 months
Change in Glycemic Variability/Fluctuations
Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period.
Measured: Screening and 15 months
Percentage of Patients With IDAA1c ≤ 9
Percentage of patients with IDAA1c ≤ 9
Measured: 15 months
Stimulated Maximum C-peptide Above 0.2 Nmol/L
Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml)
Measured: 15 months
Stimulated C-peptide Above 0.2 Nmol/L at 90 Min
Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml)
Measured: 15 months
Number of Hypoglycemias
Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts)
Measured: Baseline and 15 months
Number of Patients Having at Least 1 Severe Hypoglycemic Event
Number of patients having at least 1 severe hypoglycemic event (counts)
Measured: Baseline and 15 months
Change in Maximum C-peptide
Change in maximum C-peptide during MMTT (nmol/L)
Measured: Baseline and 15 months
Change in Fasting C-peptide
Change in Fasting C-peptide (nmol/L)
Measured: Baseline and 15 months
C-peptide Levels During a MMTT
C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months
Measured: 15 months
Change in Body Weight
Change in body weight (kg)
Measured: Baseline and 15 months
Injection Site Reactions
Injection site reactions
Measured: 15 months
Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.
Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts)
Measured: 15 months
Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations
Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal [including reflexes]).
Standardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex.
The outcome of the assessments was recored as "normal" or "abnormal"
Measured: 15 months
GAD65A Titer
GAD65A titer (IU/ml)
Measured: Baseline and 15 months
Number of Clinically Significant Abnormal Results in Vital Signs
Vital signs (blood pressure) (mmHg)
Measured: 15 months
Change in Quality of Life (QoL)
Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead.
Measured: Baseline and 15 months
Change in Body Mass Index (BMI)
Change in BMI (kg/m2)
Measured: Baseline and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start20 Dec 2017
- Primary completion13 Jul 2020
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamyd Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnny Ludvigsson, MD, Prof, Principal investigator, Universitetssjukhuset i Linköping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345004
- Sponsor's protocol ID
- DIAGNODE-2 (D/P2/17/6)
- Other IDs
- 2017-001861-25, 2017
- Status last verified
- Apr 2022
- First submitted
- 1 Nov 2017
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ludvigsson J, Wahlberg J, Casas R. Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Feb 16;376(7):697-699. doi: 10.1056/NEJMc1616343. No abstract available.
PubMed 28199812Ludvigsson J, Tavira B, Casas R. More on Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Jul 27;377(4):403-5. doi: 10.1056/NEJMc1703468. No abstract available.
PubMed 28745988Puente-Marin S, Dietrich F, Achenbach P, Barcenilla H, Ludvigsson J, Casas R. Intralymphatic glutamic acid decarboxylase administration in type 1 diabetes patients induced a distinctive early immune response in patients with DR3DQ2 haplotype. Front Immunol. 2023 Feb 2;14:1112570. doi: 10.3389/fimmu.2023.1112570. eCollection 2023.
PubMed 36817467Nowak C, Lind M, Sumnik Z, Pelikanova T, Nattero-Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Hanas R, Hernandez C, Clemente-Leon M, Gomez-Gila A, Ferrer Lozano M, Sas T, Pruhova S, Dietrich F, Puente-Marin S, Hannelius U, Casas R, Ludvigsson J. Intralymphatic GAD-Alum (Diamyd(R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2644-2651. doi: 10.1210/clinem/dgac343.
PubMed 35665810Ludvigsson J, Sumnik Z, Pelikanova T, Nattero Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Katsarou A, Hanas R, Hernandez C, Clemente Leon M, Gomez-Gila A, Lind M, Lozano MF, Sas T, Samuelsson U, Pruhova S, Dietrich F, Puente Marin S, Nordlund A, Hannelius U, Casas R. Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial. Diabetes Care. 2021 Jul;44(7):1604-1612. doi: 10.2337/dc21-0318. Epub 2021 May 21.
PubMed 34021020
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03345004
- Acronym / sponsor ID
- DIAGNODE-2 (D/P2/17/6)
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases, Metabolic Disease, Glucose Metabolism Disorders, Immune System Diseases
- Keywords
- Diamyd, Diabetes, Juvenile Diabetes, Diabetes Type 1, Type 1 Diabetes, Autoimmune Diabetes, Insulin Dependent Diabetes, Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Diamyd Medical ABIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
Detailed description
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. The patients will be followed in a blinded manner for a total of 15 months. All patients that have not performed the 15 months visit when the updated protocol is implemented, will be asked to participate in the Extension Study Period which includes an additional visit at month 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Biological: Diamyd, Dietary Supplement: Vitamin DPatients will be assigned to receive i) three (3) intralymphatic injections with Recombinant human Glutamic Acid Decarboxylase adsorbed to Alhydrogel (Diamyd) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120) |
| Placebo arm | Placebo comparator | Biological: Placebo for Diamyd, Dietary Supplement: Placebo for Vitamin DPatients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120) |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
- Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA) classification diagnosed ≤6 months at the time of screening
- Age: ≥12 and <25 years old
- Fasting C-peptide ≥0.12 nmol/L (0.36 ng/ml) on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
- Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but < 50 000 IU/ml
Key exclusion criteria (15 listed)
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Treatment with any oral or injected anti-diabetic medications other than insulin
- A history of anemia or significantly abnormal hematology results at screening
- A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiamydAlso: GAD-alumAlhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65) | Biological | Active arm |
| Vitamin DOil suspension of Vitamin D | Dietary supplement | Active arm |
| Placebo for DiamydAlhydrogel® only | Biological | Placebo arm |
| Placebo for Vitamin DPlacebo oil suspension for Vitamin D | Dietary supplement | Placebo arm |
Primary outcome
Change in Stimulated C-peptide During a MMTT
Time frame: Baseline and 15 months
Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve [AUC] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.
20 secondary outcomes
Change in IDAA1c
Time frame: Baseline and 15 months
Change in HbA1c
Time frame: Baseline and 15 months
Change in Insulin Consumption
Time frame: Baseline and 15 months
Change in Glycemic Variability/Fluctuations
Time frame: Screening and 15 months
Percentage of Patients With IDAA1c ≤ 9
Time frame: 15 months
Stimulated Maximum C-peptide Above 0.2 Nmol/L
Time frame: 15 months
Stimulated C-peptide Above 0.2 Nmol/L at 90 Min
Time frame: 15 months
Number of Hypoglycemias
Time frame: Baseline and 15 months
Number of Patients Having at Least 1 Severe Hypoglycemic Event
Time frame: Baseline and 15 months
Change in Maximum C-peptide
Time frame: Baseline and 15 months
Change in Fasting C-peptide
Time frame: Baseline and 15 months
C-peptide Levels During a MMTT
Time frame: 15 months
Change in Body Weight
Time frame: Baseline and 15 months
Injection Site Reactions
Time frame: 15 months
Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.
Time frame: 15 months
Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations
Time frame: 15 months
GAD65A Titer
Time frame: Baseline and 15 months
Number of Clinically Significant Abnormal Results in Vital Signs
Time frame: 15 months
Change in Quality of Life (QoL)
Time frame: Baseline and 15 months
Change in Body Mass Index (BMI)
Time frame: Baseline and 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28199812Ludvigsson J, Wahlberg J, Casas R. Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Feb 16;376(7):697-699. doi: 10.1056/NEJMc1616343. No abstract available.
- Background: PubMed 28745988Ludvigsson J, Tavira B, Casas R. More on Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Jul 27;377(4):403-5. doi: 10.1056/NEJMc1703468. No abstract available.
- Derived from this study: PubMed 36817467Puente-Marin S, Dietrich F, Achenbach P, Barcenilla H, Ludvigsson J, Casas R. Intralymphatic glutamic acid decarboxylase administration in type 1 diabetes patients induced a distinctive early immune response in patients with DR3DQ2 haplotype. Front Immunol. 2023 Feb 2;14:1112570. doi: 10.3389/fimmu.2023.1112570. eCollection 2023.
- Derived from this study: PubMed 35665810Nowak C, Lind M, Sumnik Z, Pelikanova T, Nattero-Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Hanas R, Hernandez C, Clemente-Leon M, Gomez-Gila A, Ferrer Lozano M, Sas T, Pruhova S, Dietrich F, Puente-Marin S, Hannelius U, Casas R, Ludvigsson J. Intralymphatic GAD-Alum (Diamyd(R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2644-2651. doi: 10.1210/clinem/dgac343.
- Derived from this study: PubMed 34021020Ludvigsson J, Sumnik Z, Pelikanova T, Nattero Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Katsarou A, Hanas R, Hernandez C, Clemente Leon M, Gomez-Gila A, Lind M, Lozano MF, Sas T, Samuelsson U, Pruhova S, Dietrich F, Puente Marin S, Nordlund A, Hannelius U, Casas R. Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial. Diabetes Care. 2021 Jul;44(7):1604-1612. doi: 10.2337/dc21-0318. Epub 2021 May 21.
- Information regarding the clinical trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnny Ludvigsson, MD, Prof principal investigator
Universitetssjukhuset i Linköping
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diamyd and Vitamin D in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Diamyd Medical AB at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Sweden, Czechia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stimulated C-peptide During a MMTT (time frame: Baseline and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345004, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.