A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
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ClinicalTrials.gov Identifier: NCT00723411 |
Recruitment Status :
Terminated
(The primary endpoint at 15 months was not met.)
First Posted : July 28, 2008
Last Update Posted : October 10, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Drug: rhGAD65 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 334 participants |
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) |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
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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.
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Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Other Names:
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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.
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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.
Other Names:
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Placebo Comparator: C
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 |
- Meal stimulated C-peptide (area under the curve) [ Time Frame: 15 months ]
- HbA1c [ Time Frame: 15 months ]
- Insulin Dose [ Time Frame: 15 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | Johnny Ludvigsson, MD, PhD | Linköping University, Sweden |
Responsible Party: | Diamyd Therapeutics AB |
ClinicalTrials.gov Identifier: | NCT00723411 |
Other Study ID Numbers: |
D/P3/07/4 |
First Posted: | July 28, 2008 Key Record Dates |
Last Update Posted: | October 10, 2011 |
Last Verified: | October 2011 |
Diabetes Juvenile Diabetes Diabetes type 1 Autoimmune Diabetes Insulin dependent Diabetes Type 1 diabetes |
Type 1 diabetes mellitus Diamyd rhGAD65 GAD GAD-alum |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Aluminum sulfate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |