A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus

• Conditions: Patients for the proposed trial are those with recent onset type 1 diabetes (diagnosed within 3 months at screening).; MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2007-002728-13-GB
• Lead Sponsor: Diamyd Therapeutics AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-02
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

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.

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

Exclusion Criteria

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 ßHCG on-site 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect to preserving insulin secretion. This will be evaluated by the change from baseline to Month 15 in C peptide area under the curve mean 0-120 minutes (AUCmean 0-120 min) during an MMTT (Mixed Meal Tolerance Test). In addition, the proposed study will provide further data to evaluate the safety of Diamyd® treatment.<br>;Secondary Objective: The secondary objectives are to compare diabetes status variables between Diamyd and placebo before and after treatment, and to further confirm the safety of Diamyd.;Primary end point(s): The change from baseline (Visit 2) to Month 15 (Visit 6) in C-peptide (AUCmean 0-120 min) during an MMTT.