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EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes

Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02464033
Enrollment
20
Registered
2015-06-08
Start date
2015-05-31
Completion date
2019-02-25
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diamyd, Diabetes, Juvenile Diabetes, Diabetes Type 1, Type 1 Diabetes, Autoimmune Diabetes, Insulin Dependent Diabetes, Type 1 Diabetes MellitusType 1 Diabetes Mellitus, rhGAD65, GAD65, GAD-Alum, Diabetes Mellitus, Diabetes mellitus Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D, Etanercept

Brief summary

The objectives of this study is to: * Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept * Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion

Interventions

DRUGGAD-Alum

Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)

DRUGVitamin D
DRUGEtanercept

Sponsors

Swedish Child Diabetes Foundation
CollaboratorOTHER
Ostergotland County Council, Sweden
CollaboratorOTHER
Diamyd Medical AB
CollaboratorINDUSTRY
Johnny Ludvigsson
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Informed consent given by patients and parent(s)/legal guardian(s) 2. Type 1 diabetes according to the ADA classification, diagnosed within the previous 100 days at the time of screening 3. Age 8.00 -17.99 years at time of screening 4. Fasting C-peptide at time of screening ≥0.12 nmol/L 5. Positive for GADA but \< 50 000 Units 6. Menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test 7. Immunity against Varicella, either through previous infection or vaccination 8. Patients must follow the Swedish vaccination programme 9. Patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of GAD-alum and etanercept. Adequate contraception is as follows: For females of childbearing potential: 1. oral (except low-dose gestagen (lynestrenol and norethisterone), injectable, or implanted hormonal contraceptives (females) 2. intrauterine device (females) 3. intrauterine system (for example, progestin-releasing coil) (females) 4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate) For males of childbearing potential: a. Condom (male)

Exclusion criteria

1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted) 2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted) 3. Treatment with any oral or injected anti-diabetic medications (especially hypoglycemic agents) other than insulin 4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial 5. A history of hypercalcemia 6. A history of anaemia or significantly abnormal haematology results at screening 7. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles 8. Clinically significant history of acute reaction to vaccines or other drugs in the past 9. Treatment with any vaccine within 4 months prior to planned first administration of GAD-Alum or planned treatment with vaccine up to 4 months after the last injection with GAD-Alum, including influenza vaccine 10. Participation in other clinical trials with a new chemical entity within the previous 3 months 11. Inability or unwillingness to comply with the provisions of this protocol 12. A history of alcohol or drug abuse 13. A significant illness other than diabetes within 2 weeks prior to first dosing 14. Known human immunodeficiency virus (HIV) 15. Prior or active viral hepatitis B or C infection 16. Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the GAD-Alum and etanercept administration, respectively) 17. Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last GAD-Alum and etanercept administration, respectively 18. Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study. 19. Deemed by the investigator not being able to follow instructions and/or follow the study protocol 20. Active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active EBV or CMV 21. Hypersensitivity to the active substance in Enbrel (etanercept) or other ingredients in Enbrel 22. Active or inactive (latent) tuberculosis (TBC) at screening 23. History of malignancy or significant cardiovascular disease 24. Current or history of leukopenia, anemia and/or thrombocytopenia 25. Liver disease (clinical or hepatic enzymes \>3 times the upper limit of normal (ULN)) 26. Renal insufficiency (clinical or creatinine \>3 times the upper limit of normal (ULN)) 27. MS, undefined neurologic condition or known SLE, or anti-nuclear or known doublestranded DNA antibody positivity 28. Arrhythmia 29. Pancreatitis 30. Vitamin D serum levels \>100 nmol/L at screening

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability1 monthsNumber of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
Number of Patients With Any Abnormal Findings From Physical Examinations After BaselineMonth 1, 2, 3, 6, 9, 15 and 30Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.
Number of Patients With Clinically Significant Laboratory FindingsMonth 1, 2, 3, 6, 9, 15 and 30Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability
GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)6 monthsGAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000
Number of Patients With an Infection Reported as Adverse Event Related to Study TreatmentMonth 1, 2, 3, 6, 9, 15 and 30Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability

Secondary

MeasureTime frameDescription
C-peptide Fasting Concentration, Change From BaselineBaseline and 6 monthsC-peptide: Fasting concentration, change from baseline to 6 months
Spontaneous IL-17a SecretionBaseline, 6 months, 9 months, 15 months and 30 monthsSpontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months
GAD65-induced IL-4 SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months
GAD65-induced IL-13 SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months
C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From BaselineBaseline and 6 months at 0, 30, 60, 90 and 120 minutes post-doseWeighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test
GAD65-induced TNF-alpha SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months
GAD65-induced GM-CSF SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months
GAD65-induced MIP-1b SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months
GAD65-induced MCP-1 SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months
GAD65-induced IFN-gamma SecretionBaseline, 6 months, 9 months, 15 months, 30 monthsGAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months
Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L6 monthsNumber of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months
Hemoglobin A1c (HbA1c), Change From BaselineBaseline and 6 monthsHemoglobin A1c (HbA1c), change from baseline to 6 months
Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From BaselineBaseline and 6 monthsExogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
C-peptide: Stimulated, 90 Minute Value, Change From BaselineBaseline and 6 monthsC-peptide: Stimulated, 90 minute value, change from baseline to 6 months

Countries

Sweden

Participant flow

Participants by arm

ArmCount
GAD-Alum+Vitamin D+Etanercept
All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
20
Total20

Baseline characteristics

CharacteristicGAD-Alum+Vitamin D+Etanercept—
Age, Categorical
<=18 years
20 Participants—
Age, Categorical
>=65 years
0 Participants—
Age, Categorical
Between 18 and 65 years
0 Participants—
Age, Continuous12.36 years
STANDARD_DEVIATION 2.321
—
Body Mass Index18.38 kg/m^2
STANDARD_DEVIATION 2.141
—
Race and Ethnicity Not Collected—— Participants
Region of Enrollment
Sweden
20 participants—
Sex: Female, Male
Female
7 Participants—
Sex: Female, Male
Male
13 Participants—
Type 1 Diabetes duration81.35 days
STANDARD_DEVIATION 22.091
—

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
20 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)

GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

Time frame: 15 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)1036.19 U/mLStandard Deviation 2527.249
Primary

GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)

GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

Time frame: 30 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)347.01 U/mLStandard Deviation 1564.466
Primary

GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)

GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

Time frame: 6 months

Population: Intention To Treat (ITT)

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)2509.41 U/mLStandard Deviation 4866.515
Primary

Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment

Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability

Time frame: Month 1, 2, 3, 6, 9, 15 and 30

Population: Safety

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With an Infection Reported as Adverse Event Related to Study Treatment3 Participants
Primary

Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline

Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.

Time frame: Month 1, 2, 3, 6, 9, 15 and 30

Population: Safety

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With Any Abnormal Findings From Physical Examinations After Baseline6 Participants
Primary

Number of Patients With Clinically Significant Laboratory Findings

Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability

Time frame: Month 1, 2, 3, 6, 9, 15 and 30

Population: Safety

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With Clinically Significant Laboratory Findings0 Participants
Primary

Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability

Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse

Time frame: 1 months

Population: Safety

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With Reactions of the Injection Site as an Assessment of the Tolerability3 Participants
Primary

Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability

Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse

Time frame: 2 months

Population: Safety

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With Reactions of the Injection Site as an Assessment of the Tolerability5 Participants
Secondary

C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline

Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test

Time frame: Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose

Population: ITT, MMTT not performed for 2 patients hence no data available for 2 out of the 20 patients

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline-0.09 nmol/L*minStandard Deviation 0.153
Secondary

C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline

Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months

Time frame: Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline-0.30 nmol/L*minStandard Deviation 0.158
Secondary

C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline

Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months

Time frame: Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose

Population: ITT, , MMTT not performed for 1 patient hence no data available for 1 out of the 20 patients

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline-0.40 nmol/L*minStandard Deviation 0.168
Secondary

C-peptide Fasting Concentration, Change From Baseline

C-peptide: Fasting, concentration, change from baseline to 30 months

Time frame: Baseline and 30 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide Fasting Concentration, Change From Baseline-0.15 nmol/LStandard Deviation 0.093
Secondary

C-peptide Fasting Concentration, Change From Baseline

C-peptide: Fasting, concentration, change from baseline to 15 months

Time frame: Baseline and 15 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide Fasting Concentration, Change From Baseline-0.10 nmol/LStandard Deviation 0.091
Secondary

C-peptide Fasting Concentration, Change From Baseline

C-peptide: Fasting concentration, change from baseline to 6 months

Time frame: Baseline and 6 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide Fasting Concentration, Change From Baseline-0.02 nmol/LStandard Deviation 0.083
Secondary

C-peptide: Stimulated, 90 Minute Value, Change From Baseline

C-peptide: Stimulated, 90 minute value, change from baseline to 30 months

Time frame: Baseline and 30 months

Population: ITT, not performed for 1 patient hence no data available for 1 out of the 20 patients

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide: Stimulated, 90 Minute Value, Change From Baseline-0.49 nmol/LStandard Deviation 0.221
Secondary

C-peptide: Stimulated, 90 Minute Value, Change From Baseline

C-peptide: Stimulated, 90 minute value, change from baseline to 15 months

Time frame: Baseline and 15 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide: Stimulated, 90 Minute Value, Change From Baseline-0.35 nmol/LStandard Deviation 0.231
Secondary

C-peptide: Stimulated, 90 Minute Value, Change From Baseline

C-peptide: Stimulated, 90 minute value, change from baseline to 6 months

Time frame: Baseline and 6 months

Population: ITT, not performed for 2 patients hence no data available for 2 out of the 20 patients

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptC-peptide: Stimulated, 90 Minute Value, Change From Baseline-0.09 nmol/LStandard Deviation 0.233
Secondary

Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline

Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

Time frame: Baseline and 6 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptExogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline0.01 IUStandard Deviation 0.249
Secondary

Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline

Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

Time frame: Baseline and 15 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptExogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline0.25 IUStandard Deviation 0.342
Secondary

Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline

Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

Time frame: Baseline and 30 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptExogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline0.42 IUStandard Deviation 0.333
Secondary

GAD65-induced GM-CSF Secretion

GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced GM-CSF SecretionGM-CSF, baseline0.01 pg/mlStandard Deviation 16.96
GAD-Alum+Vitamin D+EtanerceptGAD65-induced GM-CSF SecretionGM-CSF, 6 months0.01 pg/mlStandard Deviation 18
GAD-Alum+Vitamin D+EtanerceptGAD65-induced GM-CSF SecretionGM-CSF, 9 months1.52 pg/mlStandard Deviation 24.7
GAD-Alum+Vitamin D+EtanerceptGAD65-induced GM-CSF SecretionGM-CSF, 15 months0.01 pg/mlStandard Deviation 36.95
GAD-Alum+Vitamin D+EtanerceptGAD65-induced GM-CSF SecretionGM-CSF, 30 months0.01 pg/mlStandard Deviation 6
Secondary

GAD65-induced IFN-gamma Secretion

GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IFN-gamma SecretionIFN-gamma, baseline4.39 pg/mlStandard Deviation 210.52
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IFN-gamma SecretionIFN-gamma, 6 months11.44 pg/mlStandard Deviation 223.16
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IFN-gamma SecretionIFN-gamma, 9 months22.77 pg/mlStandard Deviation 679.35
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IFN-gamma SecretionIFN-gamma, 15 months0.01 pg/mlStandard Deviation 1679.59
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IFN-gamma SecretionIFN-gamma, 30 months0.01 pg/mlStandard Deviation 227.91
Secondary

GAD65-induced IL-13 Secretion

GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-13 SecretionIL-13, Baseline0.01 pg/mlStandard Deviation 56.88
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-13 SecretionIL-13, 6 months1.67 pg/mlStandard Deviation 58.47
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-13 SecretionIL-13, 9 months5.12 pg/mlStandard Deviation 69.63
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-13 SecretionIL-13, 15 months0.01 pg/mlStandard Deviation 99
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-13 SecretionIL-13, 30 months0.01 pg/mlStandard Deviation 49.95
Secondary

GAD65-induced IL-4 Secretion

GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-4 SecretionIL-4, baseline0.01 pg/mlStandard Deviation 1.03
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-4 SecretionIL-4, 6 months0.01 pg/mlStandard Deviation 0.58
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-4 SecretionIL-4, 9 months0.01 pg/mlStandard Deviation 1.21
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-4 SecretionIL-4, 15 months0.01 pg/mlStandard Deviation 1.52
GAD-Alum+Vitamin D+EtanerceptGAD65-induced IL-4 SecretionIL-4, 30 months0.01 pg/mlStandard Deviation 0.63
Secondary

GAD65-induced MCP-1 Secretion

GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MCP-1 SecretionMCP-1, baseline0.01 pg/mlStandard Deviation 106.61
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MCP-1 SecretionMCP-1, 6 months38.54 pg/mlStandard Deviation 89.74
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MCP-1 SecretionMCP-1, 9 months0.01 pg/mlStandard Deviation 144.03
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MCP-1 SecretionMCP-1, 15 months24.42 pg/mlStandard Deviation 203.74
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MCP-1 SecretionMCP-1, 30 months37.50 pg/mlStandard Deviation 220.66
Secondary

GAD65-induced MIP-1b Secretion

GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MIP-1b SecretionMIP-1b, baseline0.01 pg/mlStandard Deviation 85.46
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MIP-1b SecretionMIP-1b, 6 months0.01 pg/mlStandard Deviation 57.78
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MIP-1b SecretionMIP-1b, 9 months0.01 pg/mlStandard Deviation 134.3
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MIP-1b SecretionMIP-1b, 15 months30.64 pg/mlStandard Deviation 302.04
GAD-Alum+Vitamin D+EtanerceptGAD65-induced MIP-1b SecretionMIP-1b, 30 months14.61 pg/mlStandard Deviation 72.54
Secondary

GAD65-induced TNF-alpha Secretion

GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months

Time frame: Baseline, 6 months, 9 months, 15 months, 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptGAD65-induced TNF-alpha SecretionTNF-alpha, baseline0.01 pg/mlStandard Deviation 348.28
GAD-Alum+Vitamin D+EtanerceptGAD65-induced TNF-alpha SecretionTNF-alpha, 6 months0.01 pg/mlStandard Deviation 89.19
GAD-Alum+Vitamin D+EtanerceptGAD65-induced TNF-alpha SecretionTNF-alpha, 9 months0.01 pg/mlStandard Deviation 355.09
GAD-Alum+Vitamin D+EtanerceptGAD65-induced TNF-alpha SecretionTNF-alpha, 15 months0.01 pg/mlStandard Deviation 362.35
GAD-Alum+Vitamin D+EtanerceptGAD65-induced TNF-alpha SecretionTNF-alpha, 30 months0.01 pg/mlStandard Deviation 206.37
Secondary

Hemoglobin A1c (HbA1c), Change From Baseline

Hemoglobin A1c (HbA1c), change from baseline to 30 months

Time frame: Baseline and 30 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptHemoglobin A1c (HbA1c), Change From Baseline7.55 mmol/molStandard Deviation 11.213
Secondary

Hemoglobin A1c (HbA1c), Change From Baseline

Hemoglobin A1c (HbA1c), change from baseline to 6 months

Time frame: Baseline and 6 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptHemoglobin A1c (HbA1c), Change From Baseline0.80 mmol/molStandard Deviation 8.433
Secondary

Hemoglobin A1c (HbA1c), Change From Baseline

Hemoglobin A1c (HbA1c), change from baseline to 15 months

Time frame: Baseline and 15 months

Population: ITT

ArmMeasureValue (MEAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptHemoglobin A1c (HbA1c), Change From Baseline6.15 mmol/molStandard Deviation 12.495
Secondary

Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L

Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months

Time frame: 15 months

Population: ITT

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L14 Participants
Secondary

Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L

Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months

Time frame: 6 months

Population: ITT

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L17 Participants
Secondary

Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L

Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months

Time frame: 30 months

Population: ITT

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GAD-Alum+Vitamin D+EtanerceptNumber of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L8 Participants
Secondary

Spontaneous IL-17a Secretion

Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months

Time frame: Baseline, 6 months, 9 months, 15 months and 30 months

Population: ITT

ArmMeasureGroupValue (MEDIAN)Dispersion
GAD-Alum+Vitamin D+EtanerceptSpontaneous IL-17a SecretionIL-17a, Baseline3.16 pg/mlStandard Deviation 8.36
GAD-Alum+Vitamin D+EtanerceptSpontaneous IL-17a SecretionIL-17a, 6 months6.07 pg/mlStandard Deviation 10.13
GAD-Alum+Vitamin D+EtanerceptSpontaneous IL-17a SecretionIL-17a, 9 months7.06 pg/mlStandard Deviation 11.35
GAD-Alum+Vitamin D+EtanerceptSpontaneous IL-17a SecretionIL-17a,15 months6.54 pg/mlStandard Deviation 7.83
GAD-Alum+Vitamin D+EtanerceptSpontaneous IL-17a SecretionIL-17a, 30 months4.75 pg/mlStandard Deviation 10.64

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026