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Type 1 Diabetes MellitusPhase 3NCT00723411

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

A Phase 3 study testing rhGAD65 in people with Type 1 Diabetes Mellitus, run by Diamyd Therapeutics AB at 70 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 20 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
rhGAD65
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
70 sitesin 9 countries
Study dates
Jul 2008to Aug 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

70 sites in 9 countries.

70 sites in 9 countries

Sweden20 sites

  • Barn- och ungdomskliniken, Lasarettet

    Borås, SE-501 82

  • Barn- och ungdomskliniken, Länssjukhuset

    Gävle, SE-801 87

  • Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården

    Gothenburg, SE-416 85

  • Barn- och ungdomskliniken, Länssjukhuset

    Halmstad, SE-301 85

  • Barn- och ungdomsmedicin, Lasarettet

    Helsingborg, SE-251 87

  • Barnkliniken, Hudiksvalls Sjukhus

    Hudiksvall, SE-824 81

  • Barn- och ungdomskliniken, Länssjukhuset Ryhov

    Jönköping, SE-551 85

  • Barn- och ungdomskliniken, Lasarettet

    Kalmar, SE-391 85

  • Barn- och ungdomskliniken, Centralsjukhuset

    Karlstad, SE-651 85

  • Barn och ungdomsmedicinska kliniken, Centralsjukhuset

    Kristianstad, SE-291 33

  • Barn- och ungdomskliniken, Universitetssjukhuset

    Linköping, SE-581 85

  • Barn- och ungdomskliniken, Universitetssjukhuset

    Lund, SE-221 85

  • Barn- och ungdomscentrum, Universitetssjukhuset MAS

    Malmö, SE-205 02

  • Barn- och ungdomskliniken, Vrinnevi sjukhus

    Norrköping, SE-601 83

  • Barn- och ungdomskliniken, Universitetssjukhuset

    Örebro, SE-701 85

  • Sachsska Barnsjukhuset, Södersjukhuset

    Stockholm, SE-118 83

  • Barn- och ungdomskliniken, NU-sjukvården/NÄL

    Trollhättan, SE-461 85

  • Barn- och ungdomskliniken, Uddevalla Sjukhus

    Uddevalla, SE-451 80

  • Barn- och ungdomskliniken, Centrallasarettet

    Västerås, SE-721 89

  • Barn- och ungdomskliniken, Centrallasarettet

    Vaxjo, SE-351 85

Other trials in Sweden

France11 sites

  • Medecine B

    Angers, 49033

  • Centre Hospitalier Universitaire de Besançon

    Besançon, 25030

  • Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique

    Bordeaux, 33076

  • Hôpital Jeanne de Flandre Sce Pédiatrie

    Lille, 59037

  • CHU Timone Enfants, Service de pédiatrie multidisciplinaire

    Marseille, 13385

  • CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1

    Montpellier, 34295

  • C.H.U.Serv.Pediatrie

    Nantes, 44093

  • Hopital Robert Debré, Service d'Endocrinologie

    Paris, 3319

  • Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,

    Paris, 75743

  • CHU Rennes

    Rennes, 35000

  • Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique

    Toulouse, 70034

Other trials in France

Italy9 sites

  • Unità Operativa di Pediatria, Policlinico

    Bologna, 40138

  • Struttura Complessa di Diabetologia, Ospedale S. Michele

    Cagliari, 09134

  • S.S. Annunziata, Clinica Pediatrica

    Chieti, 66013

  • Clinica Pediatrica, Università di Genova

    Genova, 16147

  • Reparto di Pediatria, Ospedale S. Raffaele

    Milan, 20132

  • Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliero, Universitaria di Parma, Pediatria

    Parma, 43100

  • Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia

    Roma, 00128

  • Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita

    Torino, 10126

Other trials in Italy

Spain9 sites

  • Hospital Materno-Infantil Vall Hebrón

    Barcelona, 08035

  • Hospital Materno-Infantil de Cruces

    Cruces / Barakaldo, 48903

  • Hospital Materno-Infantil Ramón y Cajal

    Madrid, 28034

  • Hospital Materno-Infantil La Paz

    Madrid, 28046

  • Hospital Materno-Infantil Carlos Haya

    Málaga, 29011

  • Hospital Materno-Infantil Vírgen del Camino

    Pamplona, 31008

  • Hospital Materno-Infantil Vírgen del Rocío

    Seville, 41013

  • Hospital Materno-Infantil Clínico de Valencia

    Valencia, 46010

  • Hospital Materno-Infantil Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany7 sites

  • Charité Campus Virchow Childrens Hospital

    Berlin, 13353

  • DRK Kliniken Westend

    Berlin, 14050

  • Hannover Kinderkrankenhaus auf der Bult

    Hanover, 30173

  • Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig

    Leipzig, 04103

  • Klinik fȕr Kinder- und Jugendmedizin

    Mȕnchen, 80804

  • KHK Wilhelmstift

    Rahlstedt, 22149

  • Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen

    Tȕbingen, 72076

Other trials in Germany

Finland6 sites

  • Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala

    Helsinki, FI-00029

  • Kuopion yliopistollinen sairaala, Lasten klinikka

    Kuopio, FI-70211

  • Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka

    Oulu, FI-90029

  • Seinäjoen keskussairaala, Lastentautien poliklinikka

    Seinäjoki, FI-60220

  • Tampereen yliopistollinen sairaala, Lasten klinikka

    Tampere, FI-33521

  • Turun yliopistollinen keskussairaala, Lastentautien Klinikka

    Turku, FI-20521

Other trials in Finland

Netherlands4 sites

  • Meander Medisch Centrum, Lokatie Elisabeth

    Amersfoort, 3816 CP

  • Diabeter

    Rotterdam, 3011 TG

  • Orbis Medisch Centrum

    Sittard-Geleen, 6162

  • Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis

    The Hague, 2566 MJ

Other trials in Netherlands

United Kingdom3 sites

  • Maternal & Child Health Sciences, University of Dundee

    Dundee, DD1 9SY

  • Children's Admin Centre

    Leicester, LE1 5WW

  • Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry

    London, E1 2AT

Other trials in United Kingdom

Slovenia1 site

  • University Medical Centre Ljubljana, Department of Pediatric Endocrinology

    Ljubljana, 1525

Other trials in Slovenia

About this study

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)

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.

Being tested
rhGAD65, Placebo
Keywords
Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhGAD65Drug

    Also called Diamyd, GAD65, GAD-Alum, GAD

    Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.

  • rhGAD65Drug

    Also called Diamyd, GAD, GAD65, GAD-Alum

    Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.

  • PlaceboDrug

    Placebo injected subcutaneously at days 1, 30, 90 and 270

Study groups in NCT00723411
Study groupRoleWhat they receive
AActive comparatorThis 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.
Receives: Drug: rhGAD65
BActive comparatorThis 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.
Receives: Drug: rhGAD65
CPlacebo comparatorThis arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Meal stimulated C-peptide (area under the curve)

    Measured: 15 months

Secondary outcomes (2)

  1. HbA1c

    Measured: 15 months

  2. Insulin Dose

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMay 2011
  4. Study completionAug 2011

Why it stopped: The primary endpoint at 15 months was not met.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723411
Sponsor's protocol ID
D/P3/07/4
Status last verified
Oct 2011
First submitted
24 Jul 2008
Last updated
10 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Tavira B, Cheramy M, Axelsson S, Akerman L, Ludvigsson J, Casas R. Effect of simultaneous vaccination with H1N1 and GAD-alum on GAD65-induced immune response. Diabetologia. 2017 Jul;60(7):1276-1283. doi: 10.1007/s00125-017-4263-x. Epub 2017 Mar 29.

    PubMed 28357504

  • Ludvigsson J, Cheramy 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.

    PubMed 24302596

  • 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.

    PubMed 22296077

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhGAD65 in people with Type 1 Diabetes Mellitus, run by Diamyd Therapeutics AB at 70 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in Sweden, France, Italy, Spain, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The primary endpoint at 15 months was not met.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Meal stimulated C-peptide (area under the curve) (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00723411, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2011.

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