A Phase 2 interventional study of Diamyd and Vitamin D in Diabetes Mellitus, Type 1, Diabetes Mellitus and Autoimmune Diseases, sponsored by Diamyd Medical AB. Completed at 18 sites in 4 countries. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by Diamyd Medical AB · Phase 2, Interventional, and Treatment
Among 13 studies testing retogatein in Diabetes Mellitus, Type 1 — none open to participants now, 1 under way, none of them phase 3. retogatein · Diabetes Mellitus, Type 1.
Among the 13 studies testing retogatein in Diabetes Mellitus, Type 1, this one is the 5th largest by enrollment, is the only one that started in 2017, is one of 9 in phase 2, and was the 11th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →None of the 13 studies testing retogatein in Diabetes Mellitus, Type 1 is open now. The open studies under Diabetes Mellitus, Type 1, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 12 Years to 24 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 109 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 50 across the 13 interventional studies. Of the 12 that completed or were terminated, 7 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 13 have an industry lead sponsor. The 6 most frequent:
Diamyd Medical AB is the lead sponsor of 3 studies on the registry; none are open to participants now.
Diamyd Medical AB has 3 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing retogatein in Diabetes Mellitus, Type 1, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For females of childbearing potential:
For males of childbearing potential:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Biological: Diamyd · Dietary Supplement: Vitamin D
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)
Biological: Placebo for Diamyd · Dietary Supplement: Placebo for Vitamin D
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.
Time frame: Baseline and 15 months
Change in IDAA1c
Change in insulin-dose-adjusted HbA1c (IDAA1c)
Time frame: Baseline and 15 months
Change in HbA1c
Change in HbA1c (mmol/mol)
Time frame: Baseline and 15 months
Change in Insulin Consumption
Change in daily exogenous insulin consumption (IU)
Time frame: 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.
Time frame: Screening and 15 months
Percentage of Patients With IDAA1c ≤ 9
Percentage of patients with IDAA1c ≤ 9
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 15 months
Change in Maximum C-peptide
Change in maximum C-peptide during MMTT (nmol/L)
Time frame: Baseline and 15 months
Change in Fasting C-peptide
Change in Fasting C-peptide (nmol/L)
Time frame: 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
Time frame: 15 months
Change in Body Weight
Change in body weight (kg)
Time frame: Baseline and 15 months
Injection Site Reactions
Injection site reactions
Time frame: 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)
Time frame: 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"
Time frame: 15 months
GAD65A Titer
GAD65A titer (IU/ml)
Time frame: Baseline and 15 months
Number of Clinically Significant Abnormal Results in Vital Signs
Vital signs (blood pressure) (mmHg)
Time frame: 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.
Time frame: Baseline and 15 months
Change in Body Mass Index (BMI)
Change in BMI (kg/m2)
Time frame: Baseline and 15 months
| Milestone | Active Arm | Placebo Arm |
|---|---|---|
| Started | 57 | 52 |
| Haplotype dr3-dq2 population month 15 | 29 | 19 |
| Completed | 56 | 51 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Unitless back-transformed from log-scale | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Change in Stimulated C-peptide During a MMTT | 0.551 ± 1.715 | 0.506 ± 2.163 | 0.663 ± 1.511 | 0.425 ± 2.436 |
Change in insulin-dose-adjusted HbA1c (IDAA1c)
| Percent of glycated hemoglobin | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Change in IDAA1c | 0.757 ± 1.851 | 0.377 ± 2.183 | 0.663 ± 1.627 | 0.667 ± 2.788 |
Change in HbA1c (mmol/mol)
| mmol/mol | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Change in HbA1c | 0.53 ± 14.57 | 1.04 ± 15.87 | 0.87 ± 14.34 | -0.98 ± 18.75 |
Change in daily exogenous insulin consumption (IU)
| IU/kg/24h | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Change in Insulin Consumption | 0.183 ± 0.285 | 0.094 ± 0.342 | 0.143 ± 0.196 | 0.153 ± 0.399 |
Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period.
| glycemic variability/fluctuation per day | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| 70-180 mg/dL (hours) | -2.479 ± 4.638 | -2.451 ± 4.012 | -1.724 ± 3.346 | -3.920 ± 4.090 |
| 50-70 mg/dL (hours) | -0.035 ± 2.416 | 0.197 ± 1.961 | 0.034 ± 2.992 | 0.581 ± 1.057 |
| <50 mg/dL (minutes) | 15.7 ± 46.7 | 9.0 ± 88.4 | 16.7 ± 59.3 | 48.1 ± 107.0 |
Percentage of patients with IDAA1c ≤ 9
| Percent of patients | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Percentage of Patients With IDAA1c ≤ 9 | 62.7 (48.1 to 75.9) | 61.4 (45.5 to 75.6) | 78.6 (59.0 to 91.7) | 40.0 (16.3 to 67.7) |
Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml)
| Percent of patients | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Stimulated Maximum C-peptide Above 0.2 Nmol/L | 92.7 (82.4 to 98.0) | 75.7 (61.1 to 86.7) | 96.6 (82.2 to 99.9) | 70.6 (44.0 to 89.7) |
Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml)
| Percent of patients | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Stimulated C-peptide Above 0.2 Nmol/L at 90 Min | 87.3 (75.5 to 94.7) | 71.4 (56.7 to 83.4) | 96.6 (82.2 to 99.9) | 64.7 (38.3 to 85.8) |
Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts)
| Episodes | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Number of Hypoglycemias | 0 | 6 | 0 | 0 |
Number of patients having at least 1 severe hypoglycemic event (counts)
| Participants | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Number of Patients Having at Least 1 Severe Hypoglycemic Event | 0 | 1 | 0 | 0 |
Change in maximum C-peptide during MMTT (nmol/L)
| nmol/L | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Change in Maximum C-peptide | -0.350 ± 0.463 | -0.300 ± 0.350 | -0.257 ± 0.400 | -0.277 ± 0.349 |
Change in Fasting C-peptide (nmol/L)
| nmol/L | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| Change in Fasting C-peptide | -0.115 ± 0.148 | -0.106 ± 0.169 | -0.081 ± 0.100 | -0.095 ± 0.190 |
C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months
| nmol/L | Active Arm | Placebo Arm | Active (HLA DR3-DQ2) | Placebo (HLA DR3-DQ2) |
|---|---|---|---|---|
| 30 min | 0.376 ± 0.295 | 0.374 ± 0.330 | 0.659 ± 0.352 | 0.580 ± 0.282 |
| 60 min | 0.536 ± 0.383 | 0.495 ± 0.411 | 0.911 ± 0.393 | 0.715 ± 0.308 |
| 90 min | 0.645 ± 0.495 | 0.562 ± 0.438 | 1.016 ± 0.415 | 0.717 ± 0.318 |
| 120 min | 0.691 ± 0.542 | 0.590 ± 0.444 | 1.065 ± 0.430 | 0.728 ± 0.317 |
Change in body weight (kg)
| Kg | Active Arm | Placebo Arm |
|---|---|---|
| Change in Body Weight | 4.3 ± 5.0 | 5.6 ± 5.4 |
Injection site reactions
| number of episodes | Active Arm | Placebo Arm |
|---|---|---|
| Injection Site Reactions | 10 | 3 |
Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts)
| number of significant abnormal results | Active Arm | Placebo Arm |
|---|---|---|
| Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis. | 11 | 3 |
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"
| Clinically significant abnormal results | Active Arm | Placebo Arm |
|---|---|---|
| Physical examination | 15 | 9 |
| Neurological examination | 4 | 0 |
GAD65A titer (IU/ml)
| IU/mL | Active Arm | Placebo Arm |
|---|---|---|
| Baseline | 731.3 ± 2302.9 | 627.3 ± 1829.9 |
| Month 15 | 19941.2 ± 23083.6 | 476.7 ± 1527.7 |
Vital signs (blood pressure) (mmHg)
| Clinically significant abnormal results | Active Arm | Placebo Arm |
|---|---|---|
| Systolic blood pressure | 0 | 0 |
| Diastolic blood pressure | 0 | 0 |
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.
| Index value | Active Arm | Placebo Arm |
|---|---|---|
| Baseline | 1.000 (0.922 to 1.000) | 1.000 (0.919 to 1.000) |
| Month 15 | 1.000 (0.919 to 1.000) | 1.000 (1.000 to 1.000) |
Change in BMI (kg/m2)
| kg/m2 | Active Arm | Placebo Arm |
|---|---|---|
| Change in Body Mass Index (BMI) | 0.8 ± 1.4 | 1.3 ± 1.6 |
Collected over Treatment-emergent adverse events, from start of Diamyd/Placebo treatment until Month 24.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Arm | 0/57 (0%) | 0/57 (0%) | 18/57 (31.6%) |
| Placebo Arm | 0/52 (0%) | 3/52 (5.8%) | 12/52 (23.1%) |
| Event | Active Arm | Placebo Arm |
|---|---|---|
| Jaw fractureInjury, poisoning and procedural complications | 0/57 | 1/52 |
| Diabetes Mellitus inadequate controlMetabolism and nutrition disorders | 0/57 | 1/52 |
| HyperglycemiaMetabolism and nutrition disorders | 0/57 | 1/52 |
| Event | Active Arm | Placebo Arm |
|---|---|---|
| NasopharyngitisInfections and infestations | 10/57 | 10/52 |
| Viral infectionInfections and infestations | 4/57 | 0/52 |
| PyrexiaGeneral disorders | 3/57 | 3/52 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/57 | 2/52 |
| Age, Continuous(years) | Active Arm | Placebo Arm | Total |
|---|---|---|---|
| Mean | 16.2 ± 3.8 | 16.6 ± 4.3 | 16.4 ± 4.1 |
| Sex: Female, Male(Participants) | Active Arm | Placebo Arm | Total |
|---|---|---|---|
| Female | 21 | 26 | 47 |
| Male | 36 | 26 | 62 |
| Race and Ethnicity Not Collected(Participants) | Active Arm | Placebo Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Jul 2020, 30 months.
Results were first posted in Jan 2023, 2 years 5 months after primary completion.
Of 50 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's 30 months is above that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Retogatein · Vitamin D
Diamyd Medical AB