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Completed

NCT Number: NCT00456027

Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)

This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).

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Key information

Conditions

Latent Autoimmune Diabetes in Adult (LADA) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alingsås Hospital, Alingsås, Sweden

Loading trial locations.

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 30-70 years of age diagnosed with type 2 diabetes within 5 years
  • Presence of GAD65 antibodies
  • Detectable C-peptide level
  • Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)
  • Written informed Consent

Key Exclusion Criteria:

  • Treatment with insulin
  • Intolerance to OHA
  • Secondary diabetes mellitus
  • History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis)
  • Treatment with any vaccine within one 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
  • Pregnancy (or planned pregnancy within one year after 2nd administration)
  • Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
  • Significant illness other than diabetes within 2 weeks prior to first dosing
  • Unwillingness to comply with the provisions of the protocol
  • Clinically significant history of acute reaction to drugs in the past
  • Treatment with immunosuppressants

Treatment and study plan

rhGAD65 formulated in Alhydrogel® (Diamyd®)

Drug

20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart

Primary outcomes

  1. The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement.

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Diamyd Therapeutics AB

Industry

Registry information

Official study title

A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Apr 4, 2007
Registry last updated
Jun 10, 2011

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.

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