Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00644501 |
Recruitment Status :
Completed
First Posted : March 26, 2008
Last Update Posted : July 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Drug: DiaPep277 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III) |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: DiaPep277
1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations. |
- Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion. [ Time Frame: every 6 months up to 24 months from T0 ]
- improved metabolic control and the insulin dose required to maintain it. [ Time Frame: every 3 months up to 24 months from T0 ]

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Ages Eligible for Study: | 18 Years to 48 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.
- Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.
Exclusion Criteria:
- The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.
- The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644501
Israel | |
Wolfson Medical Centre | |
Holon, Israel, 58100 | |
Diabetic Unit, Hadassah Medical Center | |
Jerusalem, Israel, 91120 | |
Schneider Children's Medical Centre | |
Petach Tikva, Israel, 49202 |
Principal Investigator: | Itamar Raz, MD | Hadassah Medical Center |
Responsible Party: | Andromeda Biotech Ltd. |
ClinicalTrials.gov Identifier: | NCT00644501 |
Other Study ID Numbers: |
910 |
First Posted: | March 26, 2008 Key Record Dates |
Last Update Posted: | July 11, 2013 |
Last Verified: | July 2013 |
type 1 diabetes beta cells immunomodulation immunointervention |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |