Phase 3
N=475
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01103284 ↗Enrolled (actual)
475
Serious AEs
5.3%
Results posted
May 2016
Primary outcome: Primary: Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months — -5.20; -4.83 nmol*min/L — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DiaPep277 (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Andromeda Biotech Ltd.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months |
-5.20; -4.83 | 0.33 |
| SECONDARY Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7% |
47; 47 | 0.68 |
| SECONDARY Frequency of Hypoglycemic Events |
1955; 3264 | — |
| SECONDARY Mean Number of Days With at Least One Hypoglycemic Event |
13.0; 35.4 | 0.07 |
Summary
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.
Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
Eligibility Criteria
Inclusion Criteria
- clinical diagnosis of type 1 diabetes within last 6 months
- Age 20-45 years
- fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
- BMI between 17 and 30 at screening
Exclusion Criteria
- Significant disease or condition other than type 1 diabetes
- Diabetes-related complications
- Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
Data sourced from ClinicalTrials.gov (NCT01103284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.