Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients - Full Text View

Sponsor:	Andromeda Biotech Ltd.
Information provided by:	Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:	NCT00615264

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: DiaPep277 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: DiaPep 277

U.S. FDA Resources

Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	457
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml lipid emulsion.	Drug: DiaPep277 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
2: Placebo Comparator Mannitol 40 mg in 0.5ml lipid emulsion.	Drug: Placebo Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615264

Show 34 Study Locations

Sponsors and Collaborators

Andromeda Biotech Ltd.

Investigators

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

More Information

No publications provided

Responsible Party:	Andromeda Biotech Ltd. ( Dana Elias, Program Director )
Study ID Numbers:	901, ISRCTN55429664
Study First Received:	February 4, 2008
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00615264 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; Finland: Finnish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Israel: The Israel National Institute for Health Policy Research and Health Services Research; Italy: Ministry of Health; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2009