Type one diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
1 mg DiaPep277™ or placebo will be administered subcutaneously at baseline (zero), one, three, six, nine, 12, 15, 18 and 21 months visits for a total of nine administrations.
Both treatment groups w
Sponsors
Andromeda Biotech Ltd (Israel)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At screening: 1. The patient has a diagnosis of type one diabetes mellitus according to the American Diabetes Association (ADA)/World Health Organisation (WHO) for up to 3 months (changed from 6 months on 05/03/2007) 2. Evidence of residual beta-cell function demonstrated by basal fasting C-peptide concentrations more than or equal to 0.22 nmol/l 3. Presence of one or more of the following criteria: 3.1. At least one diabetes-related autoantibody: IA-2, insulin or glutamic acid decarboxylase (GAD) at screening and/or 3.2. Age at diagnosis less than 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 Inclusion criteria removed on 05/03/2007: the patient has HbA1c of less than or equal to 9% within seven days prior to baseline visit
Exclusion criteria
Exclusion criteria: 1. The patient is treated with inhaled insulin (changed from 'has an insulin pump in situ or is treated with inhaled insulin' on 05/03/07) 2. 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 3. Patient has history of endogenous allergic reactivity 4. The patient has a known immune deficiency from any disease, or a condition associated with an immune deficiency 5. 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 6. Patients with severe renal failure at the screening visit (as defined by glomerular filtration rate less than 30 ml/min/1.73 m^2 by Cockroft and Gault calculation), hyperlipidemia is allowed 7. The patient has liver disease such as cirrhosis or chronic active hepatitis Exclusion criteria removed on 05/03/2007: severe ketonuria (+++ on urine stix testing; ++ on repeated urine stix testing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate the effect of DiaPep277™ versus placebo in patients with Type one Diabetes Mellitus on pancreatic beta-cell function as measured by stimulated C-peptide secretion after 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess the effect of DiaPep277™ on insulin dose requirement after 24 months 2. Assess the effect of DiaPep277™ versus placebo on metabolic control as measured by % HbA1c after 24 months and by glucose profile during the study 3. Assess the safety and tolerability of DiaPep277™ during the study 4. Assess the effects of DiaPep277™ on the occurrence of hypo- and hyper-glycemic events during the study | — |
Countries
Austria, Czech Republic, Finland, France, Germany, Greece, Israel, Italy, South Africa, Spain, United Kingdom
Outcome results
None listed