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
- Conditions
- Type 1 diabetesDiabetes10018424
- Registration Number
- NL-OMON49006
- Lead Sponsor
- Diamyd Medical AB
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
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
screening
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
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in C-peptide (Area Under the Curve [AUC]mean 0-120 min) during a Mixed<br /><br>Meal Tolerance Test (MMTT) between baseline to 15 months.</p><br>
- Secondary Outcome Measures
Name Time Method