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

Primary Purpose

Latent Autoimmune Diabetes in Adult (LADA)

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
rhGAD65 formulated in Alhydrogel® (Diamyd®)
Sponsored by
Diamyd Therapeutics AB
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Latent Autoimmune Diabetes in Adult (LADA) focused on measuring Type 2 Diabetes, LADA, Latent Autoimmune Diabetes in Adult, Autoimmunity, HbA1c, C-peptide

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alingsås Hospital
  • Falu Hospital
  • Capio Lundby Hospital
  • Helsingborg Hospital
  • Härnösand Hospital
  • Karlstad Central Hospital
  • Central Hospital, Kristianstad
  • Sunderby Hospital
  • University Hospital MAS
  • Vrinnevi Hospital
  • Skellefteå Hospital
  • S:t Göran Hospital
  • Stockholm South General Hospital
  • Norrlands University Hospital
  • Uppsala University Hospital
  • Växjö Central Hospital
  • Odensala Health Clinic

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2007
Last Updated
June 9, 2011
Sponsor
Diamyd Therapeutics AB
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1. Study Identification

Unique Protocol Identification Number
NCT00456027
Brief Title
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Diamyd Therapeutics AB

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Autoimmune Diabetes in Adult (LADA)
Keywords
Type 2 Diabetes, LADA, Latent Autoimmune Diabetes in Adult, Autoimmunity, HbA1c, C-peptide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rhGAD65 formulated in Alhydrogel® (Diamyd®)
Intervention Description
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl-David Agardh, MD, phD
Organizational Affiliation
University Hospital MAS, Malmö, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alingsås Hospital
City
Alingsås
Country
Sweden
Facility Name
Falu Hospital
City
Falun
Country
Sweden
Facility Name
Capio Lundby Hospital
City
Göteborg
Country
Sweden
Facility Name
Helsingborg Hospital
City
Helsingborg
Country
Sweden
Facility Name
Härnösand Hospital
City
Härnösand
Country
Sweden
Facility Name
Karlstad Central Hospital
City
Karlstad
Country
Sweden
Facility Name
Central Hospital, Kristianstad
City
Kristianstad
Country
Sweden
Facility Name
Sunderby Hospital
City
Luleå
Country
Sweden
Facility Name
University Hospital MAS
City
Malmö
Country
Sweden
Facility Name
Vrinnevi Hospital
City
Norrköping
Country
Sweden
Facility Name
Skellefteå Hospital
City
Skellefteå
Country
Sweden
Facility Name
S:t Göran Hospital
City
Stockholm
Country
Sweden
Facility Name
Stockholm South General Hospital
City
Stockholm
Country
Sweden
Facility Name
Norrlands University Hospital
City
Umeå
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Facility Name
Växjö Central Hospital
City
Växjö
Country
Sweden
Facility Name
Odensala Health Clinic
City
Östersund
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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