Status:
COMPLETED
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Lead Sponsor:
Diamyd Medical AB
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Eligibility:
All Genders
12-24 years
Phase:
PHASE2
Brief Summary
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of...
Detailed Description
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03345004
Start Date
December 20 2017
End Date
April 27 2021
Last Update
January 9 2023
Active Locations (18)
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1
Diabetes Centre, Institute of Clinical and Experimental Medicine
Prague, Czechia, 14021
2
Department of Paediatrics, University Hospital Motol
Prague, Czechia, 15006
3
Diabeter Rotterdam
Rotterdam, Netherlands, 3011 TA
4
Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces
Barakaldo, Spain, 48903