A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)

This study has been terminated.
(The primary endpoint at 15 months was not met.)
Sponsor:
Information provided by (Responsible Party):
Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:
NCT00723411
First received: July 24, 2008
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: rhGAD65
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)

Resource links provided by NLM:


Further study details as provided by Diamyd Therapeutics AB:

Primary Outcome Measures:
  • Meal stimulated C-peptide (area under the curve) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Insulin Dose [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: July 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on Days 90 and 270.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Other Names:
  • Diamyd
  • GAD65
  • GAD-Alum
  • GAD
Active Comparator: B
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on Days 90 and 270.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Other Names:
  • Diamyd
  • GAD
  • GAD65
  • GAD-Alum
Placebo Comparator: C
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
Drug: Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Male and female patients between 10 and 20 years of age
  • Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
  • Fasting C-peptide level at time of screening above 0.1 nmol/L
  • Elevated GAD65 antibodies (GADA) at time of screening

Main Exclusion Criteria:

  • Treatment with immunosuppressants or any anti-diabetic medications other than insulin
  • A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
  • Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
  • Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723411

  Show 70 Study Locations
Sponsors and Collaborators
Diamyd Therapeutics AB
Investigators
Principal Investigator: Johnny Ludvigsson, MD, PhD Linköping University, Sweden
  More Information

No publications provided by Diamyd Therapeutics AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diamyd Therapeutics AB
ClinicalTrials.gov Identifier: NCT00723411     History of Changes
Other Study ID Numbers: D/P3/07/4
Study First Received: July 24, 2008
Last Updated: October 7, 2011
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Finland: Finnish Medicines Agency
Finland: Ethics Committee
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Comité Ético de Investigación Clínica
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Italy: The Italian Medicines Agency
Italy: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
France: Agence francaise de sécurité sanitaire des produits de santé, (afssaps)
France: Institutional Ethical Committee

Keywords provided by Diamyd Therapeutics AB:
Diabetes
Juvenile Diabetes
Diabetes type 1
Autoimmune Diabetes
Insulin dependent Diabetes
Type 1 diabetes
Type 1 diabetes mellitus
Diamyd
rhGAD65
GAD
GAD-alum

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014