Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

Phase 3

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Placebo; Drug: DiaPep277

• Registration Number: NCT00615264
• Lead Sponsor: Andromeda Biotech Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Results First Submitted: 2015-11-16
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-25
• Last Update Submitted: 2016-05-25
• Results First Posted: 2016-06-06
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Mannitol 40 mg in 0.5 mL lipid emulsion.
DiaPep277	DiaPep277	DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months	Baseline and 24 Months	Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.

Trial Locations

Locations (34)

Rudolfstiftung Hospital; 🇦🇹 Vienna, Austria

Faculty Hospital; 🇨🇿 Olomouc, Czech Republic

Faculty hospital Motol.; 🇨🇿 Prague, Czech Republic

IKEM/Diabetes Centre; 🇨🇿 Praha, Czech Republic

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

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