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

Phase 3

Terminated

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: rhGAD65

• Registration Number: NCT00723411
• Lead Sponsor: Diamyd Therapeutics AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Placebo	This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
A	rhGAD65	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.
B	rhGAD65	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.

Primary Outcome Measures

Name	Time	Method
Meal stimulated C-peptide (area under the curve)	15 months

Secondary Outcome Measures

Name	Time	Method
HbA1c	15 months
Insulin Dose	15 months

Trial Locations

Locations (65)

Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala; 🇫🇮 Helsinki, Finland

Kuopion yliopistollinen sairaala, Lasten klinikka; 🇫🇮 Kuopio, Finland

Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka; 🇫🇮 Oulu, Finland

Seinäjoen keskussairaala, Lastentautien poliklinikka; 🇫🇮 Seinäjoki, Finland

Tampereen yliopistollinen sairaala, Lasten klinikka; 🇫🇮 Tampere, Finland

Turun yliopistollinen keskussairaala, Lastentautien Klinikka; 🇫🇮 Turku, Finland

Medecine B; 🇫🇷 Angers, France

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France

Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique; 🇫🇷 Bordeaux, France

Hôpital Jeanne de Flandre Sce Pédiatrie; 🇫🇷 Lille, France

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