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

Phase 2

Completed

• Conditions: Latent Autoimmune Diabetes in Adult (LADA)

• Registration Number: NCT00456027
• Lead Sponsor: Diamyd Therapeutics AB

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Status Verified: 2007-04
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Primary Completion: 2008-03
• Study Completion: 2008-04
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	30 months

Trial Locations

Locations (17)

Capio Lundby Hospital; 🇸🇪 Göteborg, Sweden

Alingsås Hospital; 🇸🇪 Alingsås, Sweden

Falu Hospital; 🇸🇪 Falun, Sweden

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Karlstad Central Hospital; 🇸🇪 Karlstad, Sweden

Härnösand Hospital; 🇸🇪 Härnösand, Sweden

Central Hospital, Kristianstad; 🇸🇪 Kristianstad, Sweden

Sunderby Hospital; 🇸🇪 Luleå, Sweden

Vrinnevi Hospital; 🇸🇪 Norrköping, Sweden

University Hospital MAS; 🇸🇪 Malmö, Sweden

Skellefteå Hospital; 🇸🇪 Skellefteå, Sweden

Stockholm South General Hospital; 🇸🇪 Stockholm, Sweden

Norrlands University Hospital; 🇸🇪 Umeå, Sweden

Odensala Health Clinic; 🇸🇪 Östersund, Sweden

S:t Göran Hospital; 🇸🇪 Stockholm, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Växjö Central Hospital; 🇸🇪 Växjö, Sweden