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

Latent Autoimmune Diabetes in Adult (LADA)

Intervention / Treatment

Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)

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

Sweden
- - 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

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

Diamyd Therapeutics AB

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