A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
NCT ID: NCT00751842
Last Updated: 2012-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
331 participants
INTERVENTIONAL
2008-09-30
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
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.
rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
C
This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.
Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270.
Interventions
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rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
10 Years
20 Years
ALL
No
Sponsors
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Diamyd Therapeutics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Jerry Palmer, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Arizona
Tucson, Arizona, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Alex Endocrine Associates
Rogers, Arkansas, United States
Children's Hospital Orange County
Orange, California, United States
Rady Children's Hospital
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Christina Care Research institute
Newark, Delaware, United States
University of Florida
Gainsville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Miami Children's Hospital Research Institute
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
University of Iowa Hospitals and Clinicals
Iowa City, Iowa, United States
Mid America Diabetes Associates
Wichita, Kansas, United States
University of Kentucky College of Medicine
Lexington, Kentucky, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
Children's Hospital
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Alzohaili Medical Consultants
Dearborn, Michigan, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
Kathryn Eckert
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Naomi Berrie Diabetes Center of Columbia University
New York, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Institute for Human Performance
Syracuse, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
University of Oklahoma, Schustermann Center Clinic
Tulsa, Oklahoma, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Regional Medical Clinic - Endocrinology
Rapid City, South Dakota, United States
LeBonheur Children's Medical Center
Memphis, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Benaroya Research Institute
Seattle, Washington, United States
Countries
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References
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Ludvigsson J, Faresjo M, Hjorth M, Axelsson S, Cheramy M, Pihl M, Vaarala O, Forsander G, Ivarsson S, Johansson C, Lindh A, Nilsson NO, Aman J, Ortqvist E, Zerhouni P, Casas R. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med. 2008 Oct 30;359(18):1909-20. doi: 10.1056/NEJMoa0804328. Epub 2008 Oct 8.
Ludvigsson J, Krisky D, Casas R, Battelino T, Castano L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Aman J, Kardell G, Neiderud Helsingborg J, Lundstrom G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanas R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NO, Akesson 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, Lopez 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.
Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
Other Identifiers
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D/P3/07/5
Identifier Type: -
Identifier Source: org_study_id