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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
Sponsor:
Information provided by (Responsible Party):
Diamyd Therapeutics AB

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: rhGAD65 Drug: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Meal stimulated C-peptide (area under the curve) [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 15 months ]
  2. Insulin Dose [ Time Frame: 15 months ]

Eligibility Criteria
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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
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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


Locations
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Sponsors and Collaborators
Diamyd Therapeutics AB
Investigators
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Principal Investigator: Johnny Ludvigsson, MD, PhD Linköping University, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Ludvigsson J, Krisky D, Casas R, Battelino T, Castaño L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Åman J, Kärdell G, Neiderud Helsingborg J, Lundström G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanås R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NÖ, Åkesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, López Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.

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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
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:
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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