- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456027
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
June 9, 2011 updated by: Diamyd Therapeutics AB
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alingsås, Sweden
- Alingsås Hospital
-
Falun, Sweden
- Falu Hospital
-
Göteborg, Sweden
- Capio Lundby Hospital
-
Helsingborg, Sweden
- Helsingborg Hospital
-
Härnösand, Sweden
- Härnösand Hospital
-
Karlstad, Sweden
- Karlstad Central Hospital
-
Kristianstad, Sweden
- Central Hospital, Kristianstad
-
Luleå, Sweden
- Sunderby Hospital
-
Malmö, Sweden
- University Hospital MAS
-
Norrköping, Sweden
- Vrinnevi Hospital
-
Skellefteå, Sweden
- Skellefteå hospital
-
Stockholm, Sweden
- Stockholm South General Hospital
-
Stockholm, Sweden
- S:t Göran Hospital
-
Umeå, Sweden
- Norrlands University Hospital
-
Uppsala, Sweden
- Uppsala University Hospital
-
Växjö, Sweden
- Växjö Central Hospital
-
Östersund, Sweden
- Odensala Health Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carl-David Agardh, MD, phD, University Hospital MAS, Malmö, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
April 3, 2007
First Submitted That Met QC Criteria
April 3, 2007
First Posted (Estimate)
April 4, 2007
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Latent Autoimmune Diabetes in Adults
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Gastrointestinal Agents
- Adjuvants, Immunologic
- Antacids
- Aluminum Hydroxide
Other Study ID Numbers
- D/P2/04/2
- EUDRACT 2004-001998-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Latent Autoimmune Diabetes in Adult (LADA)
-
Abertawe Bro Morgannwg University NHS TrustNovo Nordisk A/SUnknownLatent Autoimmune Diabetes in Adults LADAUnited Kingdom
-
Children's Hospital of PhiladelphiaCompletedLatent Autoimmune Diabetes in AdultUnited States, United Kingdom
-
Norwegian University of Science and TechnologyKarolinska Institutet; Linkoeping University; St. Olavs Hospital; Diamyd Medical...CompletedLatent Autoimmune Diabetes in AdultsNorway, Sweden
-
DeveloGen Israel, Ltd.Terminated
-
Norwegian University of Science and TechnologyWithdrawn
-
University of WashingtonGlaxoSmithKline; Seattle Institute for Biomedical and Clinical ResearchCompleted
-
Karolinska InstitutetNovo Nordisk A/S; The Swedish Research Council; Swedish Council for Working Life...CompletedType 2 Diabetes | Latent Autoimmune Diabetes in AdultsSweden
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Exerscrip...RecruitingType 1 Diabetes | Pancreatitis | Latent Autoimmune Diabetes in AdultsUnited States
-
Universidad Juárez Autónoma de TabascoCompletedLatent Autoimmune DiabetesMexico
-
Lund University HospitalLandstinget Kronoberg, SwedenCompletedDiabetes Mellitus, Adult-Onset | Diabetes, Autoimmune
Clinical Trials on rhGAD65 formulated in Alhydrogel® (Diamyd®)
-
Diamyd Therapeutics ABCompletedType 1 DiabetesSweden
-
Diamyd Medical ABRecruitingType 1 Diabetes MellitusCzechia, Spain, United States, Hungary, Netherlands, Estonia, Germany, Poland, Sweden
-
Norwegian University of Science and TechnologyKarolinska Institutet; Linkoeping University; St. Olavs Hospital; Diamyd Medical...CompletedLatent Autoimmune Diabetes in AdultsNorway, Sweden
-
Minervax ApSSimbec ResearchCompleted
-
University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
National Hepatology & Tropical Medicine Research...Cairo UniversityUnknownHepatocellular Carcinoma | Hepatitis C, ChronicEgypt
-
Baylor College of MedicineCompletedHookworm Infection | Hookworm DiseaseGabon
-
JOSE MIGUEL MORALES ASENCIONot yet recruiting
-
Baylor College of MedicineGeorge Washington University; Makerere University Walter Reed ProjectActive, not recruitingSchistosomiasis | Schistosoma MansoniUganda
-
Hoffmann-La RocheCompletedChronic Renal AnemiaBelgium, Brazil, United Kingdom, Serbia, Spain, Germany, Korea, Republic of, Turkey, Lithuania, Italy, Czechia, Argentina, Australia, Croatia, France, Greece, Israel, Malaysia, Mexico, Panama, Philippines, Poland, Russian Federation, ... and more