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

This study has been completed.
Sponsor:
Information provided by:
Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:
NCT00456027
First received: April 3, 2007
Last updated: June 9, 2011
Last verified: April 2007
  Purpose

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).


Condition Intervention Phase
Latent Autoimmune Diabetes in Adult (LADA)
Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)

Resource links provided by NLM:


Further study details as provided by Diamyd Therapeutics AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: December 2004
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)
    20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456027

Locations
Sweden
Alingsås Hospital
Alingsås, Sweden
Falu Hospital
Falun, Sweden
Capio Lundby Hospital
Göteborg, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Härnösand Hospital
Härnösand, Sweden
Karlstad Central Hospital
Karlstad, Sweden
Central Hospital, Kristianstad
Kristianstad, Sweden
Sunderby Hospital
Luleå, Sweden
University Hospital MAS
Malmö, Sweden
Vrinnevi Hospital
Norrköping, Sweden
Skellefteå Hospital
Skellefteå, Sweden
Stockholm South General Hospital
Stockholm, Sweden
S:t Göran Hospital
Stockholm, Sweden
Norrlands University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Växjö Central Hospital
Växjö, Sweden
Odensala Health Clinic
Östersund, Sweden
Sponsors and Collaborators
Diamyd Therapeutics AB
Investigators
Principal Investigator: Carl-David Agardh, MD, phD University Hospital MAS, Malmö, Sweden
  More Information

No publications provided

Responsible Party: Managing Director, Diamyd Therapeutics AB
ClinicalTrials.gov Identifier: NCT00456027     History of Changes
Other Study ID Numbers: D/P2/04/2, EUDRACT 2004-001998-25
Study First Received: April 3, 2007
Last Updated: June 9, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Diamyd Therapeutics AB:
Type 2 Diabetes
LADA
Latent Autoimmune Diabetes in Adult
Autoimmunity
HbA1c
C-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014