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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:
ClinicalTrials.gov Identifier:
NCT00723411
First Posted: July 28, 2008
Last Update Posted: October 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Diamyd Therapeutics AB
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 15 months ]
  • Insulin Dose [ Time Frame: 15 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723411


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

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
First Submitted: July 24, 2008
First Posted: July 28, 2008
Last Update Posted: October 10, 2011
Last Verified: October 2011

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases