- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460251
OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277
March 18, 2015 updated by: Rabin Medical Center
OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277 in Patients Who Have Completed Study 901 and Study 910 (Extension to 901 Phase III Study
The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study
Study Overview
Detailed Description
The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 2 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study.
The optimal dose and dosing regimen for this study will be the same as applied in the phase 3 study (901) and its extension study protocol (910), namely 1.0 mg DiaPep277® administered every 3 months.
These conditions were determined as optimal based on the outcome of the phase 2 studies.
For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Hadassah Medical Center
-
Petah-Tikva, Israel, 49202
- Schneider Children's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A patient that participated in Study 901 and received all doses of study medication, per protocol or Study 910 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.
- If a female is of childbearing potential, the subject is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study.
- Stable medical condition for diseases, other than diabetes, during 30 days before the Screening Ext Visit.
- Signed informed consent to participate in the study
- The subject is on intensive insulin therapy (basis / bolus insulin) or is willing to initiate intensive insulin therapy, or is using an insulin pump. Patients on conventional insulin regime that had HbA1c<7% over the last 6 months can be recruited without switching to intensive insulin regime.
Exclusion Criteria:
- The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject's response to treatment or the ability to complete the study.
- The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
- The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject's participation in and/or completion of the study.
- Subject has history of endogenous allergic reactivity
- The subject has known allergy to lipid emulsions.
- The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
- The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication that in the opinion of the Investigator might interfere with the study.
- The subject has any of the following clinically significant laboratory abnormalities:Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening-Ext Visit.Total bilirubin greater than 1.3 times the ULN at the Screening-Ext Visit.Subjects with severe renal failure at the Screening-Ext visit Clinically significant laboratory abnormalities, confirmed by repeat measurement,which may interfere with the assessment of safety and / or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening- Ext Visit.Fasting triglycerides >1000 mg/dL (11.3 mmol/L) at the Screening-Ext Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
- The subject is a known or suspected drug abuser.
- The subject is known to test positive for HIV antibodies.
- The subject has chronic hematologic disease.
- The subject has liver disease such as cirrhosis or chronic active hepatitis.
- The subject has received any investigational drug within 3 months prior to Visit 12, other than DiaPep277 that was administered during study 901 or 910.
- The subject has had a severe blood loss within 2 months before the first dose of the study medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Drug:Diapep277
1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
|
1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: month 38
|
month 38
|
DiaPep277-specific antibodies
Time Frame: month 38
|
month 38
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beta cell function-AUC of stimulated C-peptide from stimulated MMTT measured by radioimmunoassay
Time Frame: month 38
|
month 38
|
Percentage of patients that maintain stimulated C-peptide >/= 0.2nmol/L
Time Frame: month 38
|
month 38
|
percentage of patients that achieve glycemic target of HbA1c</=7%
Time Frame: month 38
|
month 38
|
Daily insulin dose adjusted to body weight at study end
Time Frame: month 38
|
month 38
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liat de Vries, Dr, Rabin Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (ESTIMATE)
October 26, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 19, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rmc006492ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated
Clinical Trials on DiaPep277
-
Andromeda Biotech Ltd.Completed
-
DeveloGen Israel, Ltd.Terminated
-
Hadassah Medical OrganizationWithdrawn
-
Andromeda Biotech Ltd.TerminatedType 1 DiabetesUnited States
-
Andromeda Biotech Ltd.CompletedType 1 DiabetesFrance, Italy, United Kingdom, Israel, South Africa, Spain, Austria, Czech Republic, Finland, Germany, Greece
-
Andromeda Biotech Ltd.CompletedType 1 Diabetes MellitusUnited States, Russian Federation, Israel, Spain, Lithuania, Germany, Austria, Belarus, Canada, Czech Republic, Finland, Hungary, Italy, Poland