Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult) - Full Text View

Sponsor:	Diamyd Therapeutics AB
Information provided by:	Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:	NCT00456027

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 II

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Aluminum hydroxide Algeldrate

U.S. FDA Resources

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:

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

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 February 12, 2012