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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:
Diamyd Therapeutics AB
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
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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: Double Blind (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:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
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 ]
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:
|
|
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:
|
|
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 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00723411
Show 70 Study Locations
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
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 |
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 July 21, 2017