| February 4, 2008 |
| November 4, 2009 |
| September 2005 |
| September 2011 (final data collection date for primary outcome measure) |
| Co-primaries: Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 20 minutes glucagon-stimulated test (GST) or a 2-hour MMTT [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ] |
| Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 2-hour MMTT [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00615264 on ClinicalTrials.gov Archive Site |
- Insulin daily dose required for tight glycemic control [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- Rate of hypoglycemic events [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: Yes ]
- Percent of patients that achieve HbA1c<7% [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|
- Insulin daily dose required for tight glycemic control [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- Rate of hypoglycemic events [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: Yes ]
|
| |
| Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients |
| A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients |
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Type 1 Diabetes |
- Drug: DiaPep277
- Drug: Placebo
|
- Experimental: DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml lipid emulsion.
- Placebo Comparator: Mannitol 40 mg in 0.5ml lipid emulsion.
|
| |
| |
| Active, not recruiting |
| 457 |
| December 2011 |
| September 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- A diagnosis of type 1 diabetes for up to 3 months at screening
- Insulin dependency
- Fasting C-peptide levels >= 0.22 nmol/L
- Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)
Exclusion Criteria:
- Pregnancy or intent to conceive in the next 2 years
- Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
- Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
|
| Both |
| 16 Years to 45 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Czech Republic, Finland, France, Germany, Greece, Israel, Italy, South Africa, Spain, United Kingdom |
| |
| NCT00615264 |
| Dana Elias, Program Director, Andromeda Biotech Ltd. |
| 901, ISRCTN55429664 |
| Andromeda Biotech Ltd. |
|
| Principal Investigator: |
Itamar Raz, MD |
Hadassah Medical Center, Jerusalem |
|
| Principal Investigator: |
Paolo Pozzilli, MD |
Universita Campus Bio-Medico, Rome |
|
| Principal Investigator: |
Francois Bonici, MD |
New Groote Schuur Hospital, Cape Town |
|
| Principal Investigator: |
Thomas Linn, MD |
Universitätsklinikum, Giessen |
|
|
| Andromeda Biotech Ltd. |
| November 2009 |
