A Phase IIb, Placebo-Controlled, Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Vitamin D oral drops to Investigate the Impact on the Progression of Type 1 diabetes
- Conditions
- Type 1 diabetesTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2017-001861-25-CZ
- Lead Sponsor
- Diamyd Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
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 on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 ßHCG 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: between baseline to 15 months;Main Objective: The primary objective is to evaluate the efficacy of Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen, compared to placebo in terms of preserving endogenous insulin secretion as measured by C-peptide.;Secondary Objective: The secondary objectives are to compare Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen and placebo treatment with respect to the effects on the diabetes status, treatment safety, immune system and quality of life (QoL) of the patients.;Primary end point(s): • 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 Outcome Measures
Name Time Method