NCT00435981

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

2.7 years

First QC Date

February 15, 2007

Last Update Submit

January 29, 2008

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesGAD65AutoimmunityC-peptideChildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the safety of Diamyd® 20ug.

Interventions

rhGAD65 formulated in Alhydrogel® (Diamyd®)DRUG

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Borås Hospital

Borås, SE-501 82, Sweden

Location

The Queen Silvia Children´s Hospital

Gothenburg, SE-416 85, Sweden

Location

Halmstad Hospital

Halmstad, SE-301 85, Sweden

Location

Ryhov Hospital

Jönköping, SE-551 85, Sweden

Location

Linköping University

Linköping, SE-581 85, Sweden

Location

University Hospital, MAS

Malmo, SE-205 02, Sweden

Location

Örebro University Hospital

Örebro, SE-701 85, Sweden

Location

Astrid Lindgren Children´s Hospital

Stockholm, SE-171 76, Sweden

Location

Related Publications (3)

  • Ludvigsson J, Cheramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.

    PMID: 24302596DERIVED

  • Ludvigsson J, Hjorth M, Cheramy M, Axelsson S, Pihl M, Forsander G, Nilsson NO, Samuelsson BO, Wood T, Aman J, Ortqvist E, Casas R. Extended evaluation of the safety and efficacy of GAD treatment of children and adolescents with recent-onset type 1 diabetes: a randomised controlled trial. Diabetologia. 2011 Mar;54(3):634-40. doi: 10.1007/s00125-010-1988-1. Epub 2010 Nov 30.

    PMID: 21116604DERIVED

  • Ludvigsson J, Faresjo M, Hjorth M, Axelsson S, Cheramy M, Pihl M, Vaarala O, Forsander G, Ivarsson S, Johansson C, Lindh A, Nilsson NO, Aman J, Ortqvist E, Zerhouni P, Casas R. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med. 2008 Oct 30;359(18):1909-20. doi: 10.1056/NEJMoa0804328. Epub 2008 Oct 8.

    PMID: 18843118DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAluminum CompoundsAnionsIonsElectrolytes

Study Officials

  • Johnny Ludvigsson, MD, PhD

    Div of Pediatrics, Dept of Clinical and Molecular Medicine, Faculty of Health Sciences, Linkoping University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

January 1, 2005

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

SE(8)