A Phase II, Randomised, Double-Blind, Placebo-controlled, Multi-centre Study to Investigate the Impact of Diamyd on the Progression of diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus
- Conditions
- Type 1 diabetesMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
- Registration Number
- EUCTR2004-003764-30-SE
- Lead Sponsor
- Diamyd Therapeutics AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
1. Male and female patients of any race between 10 and 18 years of age.
2. Type 1 diabetes mellitus diagnosed within the previous 18 months and the onset at least 14 days prior to Primary injection
3. C-peptide level above 0.1 nmol/l.
4. Presence of GAD65 antibodies
5. Written informed consent both from the patient and the guardian where applicable.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Secondary diabetes mellitus.
2.Treatment with immunosuppressant(s).
3. A history of anaemia or significantly abnormal haematology results at screening.
4. A history of epilepsy, head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles.
5. Clinically significant history of acute reaction to drugs in the past.
6. Treatment with any vaccine within one month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd.
7. Participation in other clinical trials with a new chemical entity within the previous 3 months.
8. Inability or unwillingness to comply with the provisions of this protocol.
9. A history of alcohol or drug abuse.
10. A significant illness other than diabetes within 2 weeks prior to first dosing.
11. HIV or hepatitis.
12. Females pregnant at the time of injection or plans for pregnancy during the next 13 months ( one year after 2 nd administration).
13. MODY- Maturity Onset Diabetes in the young, known or likely
14. Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The study is intended to evaluate the effect of 20 µg Diamyd on the preservation of pancreatic beta cell function as defined by an increase in fasting C-peptide. In addition, the proposed study will provide further data to evaluate the safety of Diamyd treatment.<br><br>The primary objective is to evaluate the efficacy of 20 µg Diamyd, versus placebo.<br><br><br><br><br><br>;Secondary Objective: The secondary objective is to evaluate the safety of 20 µg Diamyd treatment.<br><br>;Primary end point(s): The primary efficacy endpoint is the change in fasting concentration of C-peptide from baseline to 15 months after the first injection.<br>The secondary efficacy endpoints are changes from baseline to various time-points for the following variables:<br>The concentration of HbA1c<br>Fasting concentration of C-peptide <br>Concentration of C-peptide after challenge with Sustacal<br>
- Secondary Outcome Measures
Name Time Method