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

Sponsor

Diamyd Therapeutics AB (Industry)

Overall Status

Completed

CT.gov ID

NCT00456027

Collaborator

(none)

160

Enrollment

Locations

Duration (Months)

9.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Latent Autoimmune Diabetes in Adult (LADA)	Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

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. [30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Alingsås Hospital	Alingsås	Sweden
2	Falu Hospital	Falun	Sweden
3	Capio Lundby Hospital	Göteborg	Sweden
4	Helsingborg Hospital	Helsingborg	Sweden
5	Härnösand Hospital	Härnösand	Sweden
6	Karlstad Central Hospital	Karlstad	Sweden
7	Central Hospital, Kristianstad	Kristianstad	Sweden
8	Sunderby Hospital	Luleå	Sweden
9	University Hospital MAS	Malmö	Sweden
10	Vrinnevi Hospital	Norrköping	Sweden
11	Skellefteå Hospital	Skellefteå	Sweden
12	S:t Göran Hospital	Stockholm	Sweden
13	Stockholm South General Hospital	Stockholm	Sweden
14	Norrlands University Hospital	Umeå	Sweden
15	Uppsala University Hospital	Uppsala	Sweden
16	Växjö Central Hospital	Växjö	Sweden
17	Odensala Health Clinic	Östersund	Sweden