Type 1 diabetes
Conditions
Interventions
The patients will be assessed for eligibility at the screening visit (Visit 1)
2 to 4 weeks prior to start of oral treatment with vitamin D. On Visit 2 (Day
1), patients eligible for the study will
ii) oral
vitamin D 2000 IE daily for 4 months (from Day 1 through Day 120)
• Approximately 53 patients will be assigned to receive i) three (3)
intralymphatic injections of Placebo for Diamyd on Day
ii)
oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)
Sponsors
Diamyd Medical AB
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent given by patients and/or patient*s parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations 2. T1D according to the ADA classification diagnosed =12 and <25 years old 4. Fasting C-peptide >=0.12 nmol/L 5. Positive for GAD65A but < 50 000 IU/ml 6. 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: a. oral (except low*dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives b. combined (estrogen and progestogen containing) c. oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation d. intrauterine device e. intrauterine hormone-releasing system (for example, progestin*releasing coil) f. bilateral tubal occlusion g. vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate) h. male partner using condom i. abstinence from heterosexual intercourse , For males of childbearing potential: a. condom (male) b. abstinence from heterosexual intercourse
Exclusion criteria
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 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 anemia or significantly abnormal hematology results at screening 6. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles 7. Clinically significant history of acute reaction to vaccines or other drugs in the past 8. 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. 9. Participation in other clinical trials with a new chemical entity within the previous 3 months 10. Inability or unwillingness to comply with the provisions of this protocol 11. A history of alcohol or drug abuse 12. A significant illness other than diabetes within 2 weeks prior to first dosing 13. Known HIV or hepatitis 14. 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) 15. 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 16. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in C-peptide (Area Under the Curve [AUC]mean 0-120 min) during a Mixed Meal Tolerance Test (MMTT) between baseline to 15 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: • Change in insulin-dose-adjusted HbA1c (IDAA1c) between baseline and 15 months • Change in Hemoglobin A1c (HbA1c) between baseline and 15 months • Change in daily exogenous insulin consumption between baseline and 15 months. Secondary endpoints; • Other variables that indicate Diabetes Status such as plasma C-peptide, variability of blood sugar, and number of self-reported hypoglycemia. • Variables that indicate treatment safety such as occurrence of adverse events (AEs), physical examinations, hematology, urine analysis, injection site reactions, GAD65A titer, vital signs and clinical chemistry. • Variables that indicate effects on the immune system such as serum autoantibodies (and isotypes) to GAD65, serum cytokine levels, secretion of cytokines by immune cells in response to GAD65 stimulation, and proportions of immune cells in blood. • Measurements of patient QoL by questionnaire. | — |
Countries
Netherlands
Outcome results
None listed