Phase 1
Completed N=12
GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02352974 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Number of Subjects With Injection Site Reactions Month 1 — 0; 0; 0; 1 Participants
Summary
The objectives of the main study is to:
* Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen
* Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion.
The objective of the sub-study is to:
* Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal lymph gland in 3 adult patients from the main study
* Evaluate how the above mentioned treatment influences the immune system and endogenous insulin secretion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Injection Site Reactions Month 1 |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Injection Site Reactions Month 2 |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Injection Site Reactions Month 3 |
0; 0; 0; 2; 0; 0 | — |
| PRIMARY Number of Subjects With Injection Site Reactions Month 32 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15 |
-0.11 | — |
| SECONDARY Mean Change in C-peptide AUC(Mean 120min) Value, Month 30 |
-0.22 | — |
| SECONDARY Mean Change in C-peptide AUC(Mean 120min) Value, Month 43 |
-0.13 | — |
| SECONDARY Mean Change in C-peptide 90-minute Value, Month 15 |
-0.16 | — |
| SECONDARY Mean Change in C-peptide 90-minute Value, Month 30 |
-0.29 | — |
| SECONDARY Mean Change in C-peptide 90-minute Value, Month 43 |
-0.16 | — |
| SECONDARY Mean Change in Fasting C-peptide Value, Month 15 |
-0.03 | — |
| SECONDARY Mean Change in Fasting C-peptide Value, Month 30 |
-0.10 | — |
| SECONDARY Mean Change in Fasting C-peptide Value, Month 43 |
-0.07 | — |
| SECONDARY Mean Change in HbA1c, Month 15 |
-14.25 | — |
| SECONDARY Mean Change in HbA1c, Month 30 |
-10.67 | — |
| SECONDARY Mean Change in HbA1c, Month 43 |
-30.67 | — |
| SECONDARY External Insulin Dose, Baseline |
0.36 | — |
| SECONDARY External Insulin Dose, Month 15 |
0.34 | — |
| SECONDARY External Insulin Dose, Month 30 |
0.44 | — |
| SECONDARY External Insulin Dose, Month 43 |
0.25 | — |
| SECONDARY Mean IDAA1c Values, Baseline |
9.00 | — |
| SECONDARY Mean IDAA1c Values, Month 15 |
7.64 | — |
| SECONDARY Mean IDAA1c Values, Month 30 |
8.36 | — |
| SECONDARY Mean IDAA1c Values, Month 43 |
7.11 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent given by patients
- Type 1 diabetes according to the ADA (American Diabetes Association) classification with < 6 months diabetes duration
- Age 12.00-29.99 years at diagnosis of Type 1 diabetes
- Fasting C-peptide ≥0.12 nmol/L
- Pos GADA(Antibodies to GAD with molecular mass 65,000) but < 50 000 random units
- Females must agree to avoid pregnancy and have a negative urine pregnancy test
- Patients of childbearing potential must agree to using adequate contraception, until 1 year after the last administration of GAD-Alum.
Exclusion Criteria
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with any 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
- Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
- A history of anaemia or significantly abnormal haematology results at screening
- A history of epilepsy, head trauma or cerebro-vascular 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
- 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 human immunodeficiency virus (HIV) or hepatitis
- Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG (beta-human chorionic gonadotropin) on-site within 24 hours prior to the GAD-Alum treatment)
- Males or females not willing to use adequate contraception until 1 year after the last GAD-Alum treatment
- 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
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Data sourced from ClinicalTrials.gov (NCT02352974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.