Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

NCT ID: NCT00615264

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 457 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-01-31

Brief Summary

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DiaPep277

DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.

Group Type: EXPERIMENTAL

DiaPep277

Intervention Type: DRUG

1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months

Placebo

Mannitol 40 mg in 0.5 mL lipid emulsion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Interventions

DiaPep277

1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months

Intervention Type: DRUG

Placebo

Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andromeda Biotech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Itamar Raz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Center, Jerusalem

Paolo Pozzilli, MD

Role: PRINCIPAL_INVESTIGATOR

Universita Campus Bio-Medico, Rome

Francois Bonici, MD

Role: PRINCIPAL_INVESTIGATOR

New Groote Schuur Hospital, Cape Town

Thomas Linn, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum, Giessen

Locations

Rudolfstiftung Hospital

Vienna, , Austria

Faculty Hospital

Olomouc, , Czechia

Faculty hospital Motol.

Prague, , Czechia

IKEM/Diabetes Centre

Prague, , Czechia

Pohjois-Karjala projektin tutkimussäätiö

Joensuu, , Finland

Tutkimusyksikkö Oulu

Oulu, , Finland

Diabetestutkimus

Vantaa, , Finland

CHU de Grenoble

Grenoble, , France

Hopital Edouard Herriot

Lyon, , France

Hopital La Timone

Marseille, , France

CHU de Nîmes/ Hôpital Caremeau

Nîmes, , France

Universitätsklinikum

Giessen, , Germany

Diabetes Centre for Children and Adolescents

Hanover, , Germany

Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin

Munich, , Germany

Laiko hospital

Athens, , Greece

Wolfson Medical Centre

Holon, , Israel

Hadassah University Hospital

Jerusalem, , Israel

Schneider Children's Medical Centre

Petah Tikva, , Israel

Universita' degli Studi di Bari

Bari, , Italy

Ex Istituto di clinica medica

Palermo, , Italy

University Campus Bio-Medico

Rome, , Italy

Università "La Sapienza"

Rome, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Helderberg Clinical Trials Unit

Cape Town, , South Africa

New Groote Schuur Hospital

Cape Town, , South Africa

102 Parklands Medical Centre

Durban, , South Africa

Donald Gordon Medical Center

Johannesburg, , South Africa

Centre for Diabetes and Endocrinology

Johannesburg, , South Africa

Hospital de la Santa Creu

Barcelona, , Spain

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Hospital de Sabadell

Sabadell, , Spain

Hospital Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, , Spain

St. Bartholomew's Hospital

London, , United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Countries

Austria; Czechia; Finland; France; Germany; Greece; Israel; Italy; South Africa; Spain; United Kingdom

References

Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Prochazka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391.

Reference Type: DERIVED

PMID: 24757230 (View on PubMed)

Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9.

Reference Type: DERIVED

PMID: 24408401 (View on PubMed)

Other Identifiers

ISRCTN55429664

Identifier Type: -

Identifier Source: secondary_id

901

Identifier Type: -

Identifier Source: org_study_id