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

This study is ongoing, but not recruiting participants.

First Received: April 3, 2007 No Changes Posted

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

Purpose

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).

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Aluminum hydroxide Algeldrate

U.S. FDA Resources

Further study details as provided by Diamyd Therapeutics AB:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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

Estimated Enrollment:	160
Study Start Date:	December 2004

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
University Hospital MAS
Malmö, Sweden
Uppsala University Hospital
Uppsala, Sweden
Alingsås Hospital
Alingsås, Sweden
Norrlands University Hospital
Umeå, Sweden
Skellefteå Hospital
Skellefteå, Sweden
Falu Hospital
Falun, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Capio Lundby Hospital
Göteborg, Sweden
Härnösand Hospital
Härnösand, Sweden
S:t Göran Hospital
Stockholm, Sweden
Karlstad Central Hospital
Karlstad, Sweden
Stockholm South General Hospital
Stockholm, Sweden
Central Hospital, Kristianstad
Kristianstad, Sweden
Växjö Central Hospital
Växjö, Sweden
Odensala Health Clinic
Östersund, Sweden
Vrinnevi Hospital
Norrköping, Sweden
Sunderby Hospital
Luleå, 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

Study ID Numbers:	D/P2/04/2, EUDRACT 2004-001998-25
Study First Received:	April 3, 2007
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00456027 History of Changes
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:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus

Adjuvants, Immunologic
Endocrine System Diseases
Pharmacologic Actions
Aluminum Hydroxide
Diabetes Mellitus, Type 1
Antacids
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2009