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

This study has been terminated.
(Based on other clinical trial results it was unlikely the study would meet the efficacy endpoints)
Sponsor:
Information provided by (Responsible Party):
Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:
NCT00751842
First received: September 11, 2008
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

The intended purpose of this study was 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.

Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 (USA)

Resource links provided by NLM:

U.S. FDA Resources

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: 331
Study Start Date: September 2008
Study Completion Date: July 2012
Primary Completion Date: March 2012 (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.
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.
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:

  • 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
  • Male and female patients between 10 and 20 years of age

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751842

  Show 43 Study Locations
Sponsors and Collaborators
Diamyd Therapeutics AB
Investigators
Principal Investigator: Jerry Palmer, Professor University of Washington
  More Information

Publications:

Responsible Party: Diamyd Therapeutics AB
ClinicalTrials.gov Identifier: NCT00751842     History of Changes
Other Study ID Numbers: D/P3/07/5
Study First Received: September 11, 2008
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013