A phase III, multinational, randomised, double-blind, placebo-controlled, parallel-group study to investigate the clinical efficacy and safety of Diapep277 in newly diagnosed type I Diabetes patients. - NA
- Conditions
- Type I DiabetesMedDRA version: 7.0Level: LLTClassification code 10045228
- Registration Number
- EUCTR2005-002590-73-GR
- Lead Sponsor
- Andromeda Biotech Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Patients meeting all of the following inclusion criteria at screening should be considered for admission to the study:
1. The patient has a diagnosis of T1D mellitus according to the ADA/WHO for up to 3 months.
2. Evidence of residual beta-cell function demonstrated by basal fasting C-peptide concentrations = 0.22 nmol/L.
3. Presence of 1 or more of the following criteria:
•at least 1 diabetes-related autoantibody: IA-2, insulin or GAD at screening;
•and/or: age at diagnosis < 20 years and ketonuria at diagnosis.
4. The patient is on insulin treatment for diabetes since diagnosis.
5. The patient is male or female, aged 16 to 45 years, inclusive.
6. If a female of child-bearing potential, the patient is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study. The partners of male patients, who are of child-bearing potential, should also use adequate contraception in order to avoid pregnancies.
7. Stable medical condition for diseases, other than diabetes, during 30 days before screening visit.
8. Body mass index (BMI) equal to or greater than 17 kg/m2 at screening visit
9. Signed informed consent to participate in the study
10. Ability to comply with all study requirements.
11. The patient is on intensive insulin therapy (basis/bolus insulin) or is willing to initiate intensive insulin therapy or is using an insulin pump.
Patients meeting the following inclusion criteria at baseline visit (visit 1) are considered eligible for randomization:
1.The patient has a diagnosis of T1D mellitus according to the ADA/WHO for up to 4 months.
2.The patient has NOT
• had mean blood glucose levels > 200 mg/dl during any 3 days within the week before baseline visit
• ketoacidosis
• Ketonuria on urine stix testing (+)
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
Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study.
1. The patient is treated with inhaled insulin.
2. The patient has had unintentional/unplanned weight loss of = 10 percent of body weight within the previous 6 months.
3. The patient has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the patient's response to treatment or the ability to complete the study.
4. The patient has a history of any kind of malignant tumor (not including basal cell skin cancer).
5. The patient has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the patient's participation in and/or completion of the study.
6. Patient has history of endogenous allergic reactivity:
•Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to screening visit.
•Ongoing systemic asthma treatment.
•Patients with history of life threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator’s judgment.
7. The patient has known allergy to lipid emulsions.
8. The patient has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
9. The patient is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication that, in the opinion of the Investigator, might interfere with the study.
10. The patient has any of the following clinically significant laboratory abnormalities:
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the screening visit.
•Total bilirubin greater than 1.3 times the ULN at the screening visit.
•Patients with severe renal failure at the screening visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft und Gault calculation [13])
•Clinically significant laboratory abnormalities, confirmed by repeat measurement, that may interfere with the assessment of safety and/or efficacy of the study drug, other than hyperglycemia and glycosuria at the screening visit.
•Fasting triglycerides > 1000 mg/dL (11.3 mmol/L) at the screening visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
11. The patient is a known or suspected drug abuser.
12. The patient is known to test positive for HIV antibodies.
13. The patient has chronic hematologic disease.
14. The patient has liver disease such as cirrhosis or chronic active hepatitis.
15. The patient has received any investigational drug within 3 months prior to
Visit 1.
16. The patient has already been treated with DiaPep277TM.
17. The patient has had a severe blood loss (= 400 mL, e.g., blood donation) within 2 months before the first dose of the study medication.
For forbidden prior and concomitant medications/treatments please refer to section 8.2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method