Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

NCT00615264 | Completed Phase 3 Results DMC

• 2 other identifiers: 901ISRCTN55429664
• Study Type: interventional
• Target: 457
• Locations: 11 countries
• Sites: 34

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months

  Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration \[area under the curve (AUC), 0-20 minutes\] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.

  Baseline and 24 months

Secondary Outcomes (1)

• Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months

  Baseline and 24 Months

Study Arms (2)

DiaPep277

EXPERIMENTAL

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

Drug: DiaPep277

Placebo

PLACEBO COMPARATOR

Mannitol 40 mg in 0.5 mL lipid emulsion.

Drug: Placebo

Interventions

DiaPep277 DRUG

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

DiaPep277

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andromeda Biotech Ltd.: lead

Study Sites (34)

Rudolfstiftung Hospital

Vienna, 1030, Austria

Location

Faculty Hospital

Olomouc, 775 20, Czechia

Location

Faculty hospital Motol.

Prague, 150 06, Czechia

Location

IKEM/Diabetes Centre

Prague, 4 140 21, Czechia

Location

Pohjois-Karjala projektin tutkimussäätiö

Joensuu, 80100, Finland

Location

Tutkimusyksikkö Oulu

Oulu, 90220, Finland

Location

Diabetestutkimus

Vantaa, 01300, Finland

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hopital Edouard Herriot

Lyon, 69003, France

Location

Hopital La Timone

Marseille, 13005, France

Location

CHU de Nîmes/ Hôpital Caremeau

Nîmes, 30029, France

Location

Universitätsklinikum

Giessen, 35392, Germany

Location

Diabetes Centre for Children and Adolescents

Hanover, 30173, Germany

Location

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

Munich, 80804, Germany

Location

Laiko hospital

Athens, 11572, Greece

Location

Wolfson Medical Centre

Holon, 58100, Israel

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Schneider Children's Medical Centre

Petah Tikva, 49202, Israel

Location

Universita' degli Studi di Bari

Bari, 70124, Italy

Location

Ex Istituto di clinica medica

Palermo, 90127, Italy

Location

University Campus Bio-Medico

Rome, 00155, Italy

Location

Università "La Sapienza"

Rome, 00161, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Helderberg Clinical Trials Unit

Cape Town, 7129, South Africa

Location

New Groote Schuur Hospital

Cape Town, 7925, South Africa

Location

102 Parklands Medical Centre

Durban, 4091, South Africa

Location

Donald Gordon Medical Center

Johannesburg, 2193, South Africa

Location

Centre for Diabetes and Endocrinology

Johannesburg, 2198, South Africa

Location

Hospital de la Santa Creu

Barcelona, 08041, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 5198, Spain

Location

Hospital de Sabadell

Sabadell, Spain

Location

Hospital Nuestra Señora de La Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, SY3 8XQ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24757230 DERIVED

• 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.

  PMID: 24408401 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Jeanne Novak
• Organization: CBR International

jnovak@cbrintl.com

7207461190

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 14, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-05

Locations

DE (3); CZ (3); IT (5); AU (1); GB (2); FR (4); FI (3); ZA (5); GR (1); ES (4); IL (3)