A Phase III, 3-Arm, Randomized, 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
- diabetes mellitus type Idiabetes1001842410003816
- Registration Number
- NL-OMON33991
- Lead Sponsor
- Diamyd Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Male and female patients between 10 and 20 years of age
2. Insulin dependent type 1 diabetes mellitus diagnosed within the previous
3 months at time of screening
3. Fasting C-peptide level at time of screening above 0.1 nmol/L
4. Elevated GAD65 antibodies (GADA) at time of screening
5. Menarchal females must agree to avoid pregnancy and have a negative urine
pregnancy test
6. Patients must agree to using adequate contraception, if sexually active, until 1
year after the last study drug administration
7. Must be willing to comply with intensive diabetes management
8. Written informed consent obtained from the patient and/or patient*s parents or
legal acceptable representative(s) according to local regulations.
1. Previous or current treatment with immunosuppressant therapy (although
topical or inhaled steroids are accepted)
2. Treatment with any oral or injected anti-diabetic medications other than insulin
3. A history of anemia or significantly abnormal hematology 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 vaccines or other drugs in the
past
6. Treatment with any vaccine within 1 month prior to planned first Diamyd dose
or planned treatment with vaccine up to 2 months after the last injection with
Diamyd, excluding the influenza vaccine
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. Known human immunodeficiency virus (HIV) or hepatitis
12. Females who are lactating or pregnant (for females who have started
menstruating the possibility of pregnancy must be excluded by urine βHCG onsite
within 24 hours prior to the investigational product administration)
13. Males or females not willing to use adequate contraception, if sexually active,
until 1 year after the last study drug administration
14. Presence of associated serious disease or condition, including active skin
infections that preclude subcutaneous injection, which in the opinion of the
investigator makes the patient non-eligible for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The change from baseline (Visit 2) to Month 15 (Visit 6) in C-peptide (AUCmean<br /><br>0-120 min) during an MMTT.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Hemoglobin A1c (HbA1c), change between baseline and subsequent visits<br /><br>• Exogenous insulin dose per kg body weight and 24 hours, change between<br /><br>baseline and subsequent<br /><br>visits<br /><br>• Number of self-reported episodes of hypoglycemia<br /><br>• Fasting C-peptide, change between baseline and subsequent visits<br /><br>• C-peptide AUCmean 0-120 min during MMTT, change between baseline and<br /><br>subsequent visits<br /><br>• C-peptide measured at 30, 60, 90, and 120 minutes during MMTT<br /><br>• Maximum C-peptide during MMTT, change between baseline and subsequent visits<br /><br>• Proportion of patients with a stimulated maximum C-peptide level above 0.2<br /><br>nmol/L<br /><br>+ safety variables as observation of reactions at the injection site, GAD65Ab<br /><br>titer, occurrence of<br /><br>adverse events (AEs), findings from: laboratory measurements, vital signs,<br /><br>neurological assessments, and limited physical<br /><br>examination.</p><br>