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 one diabetes patients
- Conditions
- Type one diabetesNutritional, Metabolic, EndocrineType 1 diabetes mellitus
- Registration Number
- ISRCTN55429664
- Lead Sponsor
- Andromeda Biotech Ltd (Israel)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Assess the effect of DiaPep277™ on insulin dose requirement after 24 months<br>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<br>3. Assess the safety and tolerability of DiaPep277™ during the study<br>4. Assess the effects of DiaPep277™ on the occurrence of hypo- and hyper-glycemic events during the study