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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
rhGAD65 formulated in Alhydrogel® (Diamyd®)
Sponsored by
Diamyd Therapeutics AB
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, GAD65, Autoimmunity, C-peptide, Children

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Borås Hospital
  • The Queen Silvia Children´s Hospital
  • Halmstad Hospital
  • Ryhov Hospital
  • Linköping University
  • University Hospital, MAS
  • Astrid Lindgren Children´s Hospital
  • Örebro University Hospital

Outcomes

Primary Outcome Measures

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

To evaluate the safety of Diamyd® 20ug.

Full Information

First Posted
February 15, 2007
Last Updated
January 29, 2008
Sponsor
Diamyd Therapeutics AB
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1. Study Identification

Unique Protocol Identification Number
NCT00435981
Brief Title
Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Diamyd Therapeutics AB

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, GAD65, Autoimmunity, C-peptide, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rhGAD65 formulated in Alhydrogel® (Diamyd®)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the safety of Diamyd® 20ug.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Ludvigsson, MD, PhD
Organizational Affiliation
Div of Pediatrics, Dept of Clinical and Molecular Medicine, Faculty of Health Sciences, Linkoping University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borås Hospital
City
Borås
ZIP/Postal Code
SE-501 82
Country
Sweden
Facility Name
The Queen Silvia Children´s Hospital
City
Göteborg
ZIP/Postal Code
SE-416 85
Country
Sweden
Facility Name
Halmstad Hospital
City
Halmstad
ZIP/Postal Code
SE-301 85
Country
Sweden
Facility Name
Ryhov Hospital
City
Jönköping
ZIP/Postal Code
SE-551 85
Country
Sweden
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
University Hospital, MAS
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Astrid Lindgren Children´s Hospital
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
SE-701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24302596
Citation
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.
Results Reference
derived
PubMed Identifier
21116604
Citation
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.
Results Reference
derived
PubMed Identifier
18843118
Citation
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.
Results Reference
derived

Learn more about this trial

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

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