Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Borås Hospital, Borås, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months
Fasting C-peptide level above 0.1 nmol/l
Presence of GAD65 antibodies
Written informed consent (patient and parent/guardian)

Key Exclusion Criteria:

Secondary diabetes mellitus or MODY
Treatment with immunosuppressants
Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
Participation in other clinical trials with a new chemical entity within the previous 3 months
History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse)
HIV or hepatitis
Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Pregnancy (or planned pregnancy within one year after 2nd administration)

Treatment and study plan

rhGAD65 formulated in Alhydrogel® (Diamyd®)

Drug

Primary outcomes

To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase).

Secondary outcomes

To evaluate the safety of Diamyd® 20ug.

Sponsors and collaborators

Lead sponsor

Diamyd Therapeutics AB

Industry

Registry information

Official study title

A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Feb 16, 2007
Registry last updated: Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed