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

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum

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.

Tavira B, Tavira B, Cheramy M, Axelsson S, Åkerman L, Ludvigsson J, Casas R.

2017-03-299 citations

10.1007/s00125-017-4263-x

How many unpublished studies? ClinicalTrials.gov (n = 2614 studies): diabetes | Closed Studies | Interventional Studies | Phase 3, 4 | Search Date: Oct 27, 2014

Ramirez Jorge H

Figshare2014-01-01

10.6084/m9.figshare.1249628.v1

GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus.

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.

2012-02-01237 citations

10.1056/nejmoa1107096

Interventions

DRUGrhGAD65

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 20 Years

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Meal stimulated C-peptide (area under the curve)	15 months

Secondary

Measure	Time frame
HbA1c	15 months
Insulin Dose	15 months

Countries

Finland, France, Germany, Italy, Netherlands, Slovenia, Spain, Sweden, United Kingdom

Outcome results

None listed