Efficacy and Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult) - Tabular View

Tracking Information

First Received Date ^ICMJE

April 3, 2007

Last Updated Date

April 3, 2007

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Evaluation of the change in C-peptide levels, the proportion of patients developing insulin dependency and safety variables.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This is a randomized, placebo-controlled Multi-Center Phase II/III study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, can preserve insulin production in patients with Latent Autoimmune Diabetes in Adult (LADA).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Latent Autoimmune Diabetes in Adult (LADA)

Intervention ^ICMJE

Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

160

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00456027

Responsible Party

Study ID Numbers ^ICMJE

D/P2/04/2, EUDRACT 2004-001998-25

Study Sponsor ^ICMJE

Diamyd Therapeutics AB

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Carl-David Agardh, MD, phD

University Hospital MAS, Malmö, Sweden

Information Provided By

Diamyd Therapeutics AB

Verification Date

April 2007

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