A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU) - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Diabetes Medicines Diabetes Type 1

Drug Information available for: Alum, potassium Aluminum sulfate anhydrous Aluminum sulfate

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Insulin Dose [ Time Frame: 15 months ] [ Designated as safety issue: No ]


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: 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

Eligibility


Ages Eligible for Study:	10 Years to 20 Years
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

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

No publications provided by Diamyd Therapeutics AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ludvigsson J, Chéramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.

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.


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
Health Authority:	Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Finland: Finnish Medicines Agency 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 Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission France: Agence francaise de sécurité sanitaire des produits de santé, (afssaps) France: Institutional Ethical Committee

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 Autoimmune Diseases Endocrine System Diseases	Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases

ClinicalTrials.gov processed this record on February 25, 2015