Type I Diabetes MedDRA version: 14.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: DiaPep277
Product Code: DiaPep277
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: DIAPEP277™
CAS Number: 179822-83-4
Current Sponsor code: PO-10
Sponsors
Andromeda Biotech Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 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 of the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the effect of DiaPep277™ versus placebo in patients with Type 1 Diabetes Mellitus (T1D) on pancreatic beta-cell function as measured by glucagon stimulated C-peptide secretion.;Secondary Objective: Key Secondary: • Assess the effect of DiaPep277® on metabolic control • Investigate the effect of DiaPep277® on MMTT-stimulated C-peptide secretion • Investigate the effect of DiaPep277® on basal, fasting C-peptide secretion Exploratory Secondary: • Assess the effect of DiaPep277® on glycemic excursions • Other parameters for Beta-cell function • Immunological response Safety: • Assess the safety and tolerability of DiaPep277® ;Primary end point(s): To demonstrate the efficacy of add-on therapy with DiaPep277® on intensive insulin therapy in subjects with newly diagnosed T1D, by testing the hypothesis that pancreatic beta-cell function with DiaPep277® is superior to that with placebo after 24 months (9 administrations, 21 months treatment, 3 months follow up). Primary efficacy endpoint will be the difference in beta-cell function between Placebo and DiaPep277® treated, as determined by change from baseline in glucagon-stimulated C-peptide AUC secretion | — |
Countries
Czech Republic, Finland, Germany, Greece, Italy, Spain, United Kingdom
Outcome results
None listed