Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

NCT01898286 | Terminated Phase 3 Results DMC

• 2 other identifiers: 10102013-002775-17
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

Conditions

Type 1 Diabetes

Keywords

C peptide; beta cell function; immune modulation of type 1 diabetes; immune intervention in type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Hypoglycemic Events

  The number of hypoglycemic events recorded by each patient over the course of the study.

  At Early Termination Visit, Up to 25 Months

Secondary Outcomes (1)

• Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit

  Baseline and Early Termination Visit, Up to 25 Months

Other Outcomes (2)

• Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit

  Baseline and Early Termination Visit, up to 25 months

• Glycemic Control (Change From Baseline in % HbA1c)

  Baseline and Early Termination Visit, Up to 25 Months

Study Arms (1)

DiaPep277®

EXPERIMENTAL

Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)

Drug: DiaPep277®

Interventions

DiaPep277® DRUG

1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations

DiaPep277®

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with type 1 diabetes who participated in the 1001 study
• residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.

You may not qualify if:

• The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
• The subject has a history of any kind of malignant tumor.
• The subject has clinical evidence of any diabetes-related complication
• Subject has history of endogenous allergic reactivity:
• The subject has a known immune deficiency

Sponsors & Collaborators

• Andromeda Biotech Ltd.: lead

Study Sites (3)

Atlanta Diabetes associates

Atlanta, Georgia, 30318, United States

Location

Henry Ford Medical Centers - New Center One

Detroit, Michigan, 48202, United States

Location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

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

Limitations and Caveats

The objectives of this study were to evaluate the safety and tolerability of long term treatment with DiaPep277. The study was terminated by the Sponsor on 08Sep14; hence many of the protocol-specified objectives could not be adequately assessed

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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 12, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

US (3)