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

April 3, 2007
June 9, 2011
December 2004
March 2008   (final data collection date for primary outcome measure)
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 ]
To evaluate the change in HbA1c 18 months (main study period) after the prime injection of Diamyd® 20ug versus baseline in comparison with placebo. The patients will be followed for an additional 42 months (total study period of 5 years).
Complete list of historical versions of study NCT00456027 on ClinicalTrials.gov Archive Site
Not Provided
Evaluation of the change in C-peptide levels, the proportion of patients developing insulin dependency and safety variables.
Not Provided
Not Provided
 
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of 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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Latent Autoimmune Diabetes in Adult (LADA)
Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
April 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00456027
D/P2/04/2, EUDRACT 2004-001998-25
Yes
Managing Director, Diamyd Therapeutics AB
Diamyd Therapeutics AB
Not Provided
Principal Investigator: Carl-David Agardh, MD, phD University Hospital MAS, Malmö, Sweden
Diamyd Therapeutics AB
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP