Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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:
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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Diabetes Centre, Institute of Clinical and Experimental Medicine
- Department of Paediatrics, University Hospital Motol
- Diabeter Rotterdam
- Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces
- Adult Endocrinology and Diabetology, Hospital vall D' Hebrón
- Pediatrics Endocrinology and Diabetology, Hospital Vall D'Hebrón
- Adult Endocrinology and Diabetology, Hospital Ramón y Cajal
- Adult Endocrinology and Diabetology, Hospital Carlos Haya
- Pediatrics Endocrinology and Diabetology, Hospital Materno-Ifantil
- Adult Endocrinology and Diabetology, Hospital Macarena
- Pediatrics Endocrinology and Diabetology, Hospital Virgen del Rocío
- Adult and Pediatrics Endocrinology and Diabetology, Hospital Miguel Servet
- Barn- och Ungdomskliniken, Universitetssjukhuset
- Endokrinmedicinska kliniken. Universitetssjukhuset
- Barn-och Ungdomsmedicinmottagningen and Endokrinmottagningen, Skånes Universitetssjukhus
- Barn- och ungdomskliniken, Uddevalla Sjukhus
- Diabetesmottagningen, Uddevalla Sjukhus
- Barnmottagningen, Norrlands Universitetssjukhus
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active arm
Placebo arm
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)
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)