Clinical study in patients who just developed type 1 diabetes, to look at the benefit and safety of DiaPep277 compared to placebo (control).

• Conditions: Type I diabetes; MedDRA version: 17.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-015929-37-CZ
• Lead Sponsor: Andromeda Biotech Ltd, 42 Hayarkon st, Yavne, 81227, Israel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-12
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

1. The subject can be randomized within no more than 6 months following the diagnosis of T1D mellitus according to the ADA/WHO criteria (2010 update of ADA recommendations). To achieve this, subject should be screened up to 5 months after diagnosis. Any period of misdiagnosis with T2D or unspecified type should be included in the calculation, although the initial misdiagnosis itself is not basis for exclusion.
2. Evidence of residual beta-cell function demonstrated by basal fasting C-peptide concentrations = 0.22 nmol/L, but not more than 0.8 nmol/L.
3. The subject is positive for at least 1 diabetes-related autoantibody: IA-2A, IAA or GADA at screening. Subjects with only IAA must be no more than 1 month on insulin therapy.
4. The subject has been on insulin treatment for diabetes within 1 month since diagnosis of T1D mellitus.
5. The subject is male or female, aged 20 to 45 years, inclusive.
6. If a female of child-bearing potential, the subject is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study.
7. Stable medical condition for diseases, other than diabetes, during 30 days before the Screening Visit.
8. Body mass index (BMI) equal to or greater than 17 kg/m2 and not greater than 30 kg/m2 at the Screening Visit.
9. Signed informed consent to participate in the study.
10. Ability to comply with all study requirements.
11. The subject is willing to initiate intensive insulin therapy (basis and bolus insulin) at study entry, or is using an insulin pump.

Are the trial subjects under 18? no
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 474
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 The subject has a diagnosis of latent autoimmune diabetes in adults (LADA) (Pozzilli and Di Mario 2001).
2 The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
3 The subject has a prior history of any kind of malignant tumor excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
4 The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
5 Subject has history of endogenous allergic reactivity:
a. Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening Visit.
b. Ongoing systemic parenteral or oral steroids for asthma treatment.
c. Subjects with history of life-threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator’s judgment.
d. The subject has known allergy to lipid emulsions.
6 The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
7 The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication for more than 4 weeks that in the opinion of the Investigator might interfere with the study.
8 The subject has any of the following clinically significant laboratory abnormalities:
a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening Visit.
b. Total bilirubin greater than 2 times the ULN at the Screening Visit.
c. Subjects with severe renal failure at the screening visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft Gault calculation (Cockcroft and Gault 1976)).
d. Clinically significant laboratory abnormalities, confirmed by repeat measurement, which may interfere with the assessment of safety and/or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening Visit.
e. Fasting triglycerides >1000 mg/dL (11.3 mmol/L) at the Screening Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
9 The subject is a known or suspected drug abuser.
10 The subject is known to test positive for HIV antibodies.
11 The subject has chronic hematologic disease.
12 The subject has liver disease such as cirrhosis or chronic active hepatitis.
13 The subject has received any investigational drug or participated in another clinical study for the indication of prevention or treatment of diabetes, at any point in the past.
14 The subject has received any investigational drug, not diabetes-related, within 1 month prior to the Baseline Visit (Visit 1).
15 The subject has already been treated with DiaPep277®.
16 The subject has had a severe blood loss (>= 400 mL, e.g., blood donation) within 2 months before the first dose of the study medication.
17 The subject receives a forbidden medication (listed within section 7.2. of study protocol)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified