Phase 2
Completed N=20
EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02464033 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability — 3 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability |
5 | — |
| PRIMARY Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline |
6 | — |
| PRIMARY Number of Patients With Clinically Significant Laboratory Findings |
— | — |
| PRIMARY GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) |
347.01 | — |
| PRIMARY Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment |
3 | — |
| SECONDARY C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline |
-0.40 | — |
| SECONDARY Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L |
8 | — |
| SECONDARY Hemoglobin A1c (HbA1c), Change From Baseline |
7.55 | — |
| SECONDARY Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline |
0.42 | — |
| SECONDARY C-peptide: Stimulated, 90 Minute Value, Change From Baseline |
-0.49 | — |
| SECONDARY C-peptide Fasting Concentration, Change From Baseline |
-0.15 | — |
| SECONDARY Spontaneous IL-17a Secretion |
3.16; 6.07; 7.06; 6.54; 4.75 | — |
| SECONDARY GAD65-induced IL-4 Secretion |
0.01; 0.01; 0.01; 0.01; 0.01 | — |
| SECONDARY GAD65-induced IL-13 Secretion |
0.01; 1.67; 5.12; 0.01; 0.01 | — |
| SECONDARY GAD65-induced IFN-gamma Secretion |
4.39; 11.44; 22.77; 0.01; 0.01 | — |
| SECONDARY GAD65-induced TNF-alpha Secretion |
0.01; 0.01; 0.01; 0.01; 0.01 | — |
| SECONDARY GAD65-induced GM-CSF Secretion |
0.01; 0.01; 1.52; 0.01; 0.01 | — |
| SECONDARY GAD65-induced MIP-1b Secretion |
0.01; 0.01; 0.01; 30.64; 14.61 | — |
| SECONDARY GAD65-induced MCP-1 Secretion |
0.01; 38.54; 0.01; 24.42; 37.50 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent given by patients and parent(s)/legal guardian(s)
- Type 1 diabetes according to the ADA classification, diagnosed within the previous 100 days at the time of screening
- Age 8.00 -17.99 years at time of screening
- Fasting C-peptide at time of screening ≥0.12 nmol/L
- Positive for GADA but 3 times the upper limit of normal (ULN))
- Renal insufficiency (clinical or creatinine >3 times the upper limit of normal (ULN))
- MS, undefined neurologic condition or known SLE, or anti-nuclear or known doublestranded DNA antibody positivity
- Arrhythmia
- Pancreatitis
- Vitamin D serum levels >100 nmol/L at screening
Data sourced from ClinicalTrials.gov (NCT02464033). 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.