NL-OMON49006
Recruiting
Phase 2
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes - DIAGNODE-2
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 1 diabetes
- Sponsor
- Diamyd Medical AB
- Enrollment
- 2
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility 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 \<\=6 months at the time of
- •3\. Age: \>\=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
- •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:
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
- •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
Outcomes
Primary Outcomes
Not specified
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