Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

January 29, 2008 updated by: Diamyd Therapeutics AB

A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus

This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Borås, Sweden, SE-501 82
        • Boras hospital
      • Göteborg, Sweden, SE-416 85
        • The Queen Silvia Children´s Hospital
      • Halmstad, Sweden, SE-301 85
        • Halmstad Hospital
      • Jönköping, Sweden, SE-551 85
        • Ryhov Hospital
      • Linköping, Sweden, SE-581 85
        • Linköping University
      • Malmö, Sweden, SE-205 02
        • University Hospital, MAS
      • Stockholm, Sweden, SE-171 76
        • Astrid Lindgren Children´s Hospital
      • Örebro, Sweden, SE-701 85
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months
  • Fasting C-peptide level above 0.1 nmol/l
  • Presence of GAD65 antibodies
  • Written informed consent (patient and parent/guardian)

Key Exclusion Criteria:

  • Secondary diabetes mellitus or MODY
  • Treatment with immunosuppressants
  • Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse)
  • HIV or hepatitis
  • Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
  • Pregnancy (or planned pregnancy within one year after 2nd administration)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase).

Secondary Outcome Measures

Outcome Measure
To evaluate the safety of Diamyd® 20ug.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diamyd Therapeutics AB

Investigators

  • Principal Investigator: Johnny Ludvigsson, MD, PhD, Div of Pediatrics, Dept of Clinical and Molecular Medicine, Faculty of Health Sciences, Linkoping University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (ESTIMATE)

February 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/P2/04/3
  • EUDRACT 2004-003764-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on rhGAD65 formulated in Alhydrogel® (Diamyd®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe