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Sponsored by: |
Diamyd Therapeutics AB |
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Information provided by: | Diamyd Therapeutics AB |
ClinicalTrials.gov Identifier: | NCT00723411 |
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 |
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Type 1 Diabetes Mellitus |
Drug: rhGAD65 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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) |
Estimated Enrollment: | 320 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
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.
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Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
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B: Active Comparator
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.
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Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
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C: Placebo Comparator
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
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Drug: Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270
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Ages Eligible for Study: | 10 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contact: Ulf Parkhede | +46-8-4407622 | ulf.parkhede@trialformsupport.com |
Principal Investigator: | Johnny Ludvigsson, MD, PhD | Linköping University, Sweden |
Responsible Party: | Diamyd Therapeutics AB ( Managing Director ) |
Study ID Numbers: | D/P3/07/4 |
Study First Received: | July 24, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00723411 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; Finland: National Agency for Medicines; 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 |
Diabetes Juvenile Diabetes Diabetes type 1 Autoimmune Diabetes Insulin dependent Diabetes Type 1 diabetes |
Type 1 diabetes mellitus Diamyd rhGAD65 GAD GAD-alum |
Aluminum sulfate Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Disease Progression Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |