Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes

GAD Ab Positive Clinically Type 2 Diabetic Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232375
• Other study ID #: 13-81
• Status: Completed
• Phase: N/A
• First received: September 29, 2005
• Last updated: September 30, 2005
• Start date: January 1996
• Est. completion date: January 2005

Study information

• Verified date: January 2005
• Source: Tokyo Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA).

Description:

In a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (GADAb). Sixty GADAb-positive non-insulin requiring diabetic patients with duration of diabetes =/<5 years were assigned to either the SU group (n = 30) or the Insulin group (n = 30). Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects should use SU agents to obtain as a goal good glycemic control.

• Duration of diabetes within 5 years from the onset (or diagnosis).

Exclusion Criteria:

• Subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded.

• Subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• GAD Ab Positive Clinically Type 2 Diabetic Patients

Intervention

Drug:
• Insulin

Locations

Country	Name	City	State
Japan	University of Yamanashi	Tamaho	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).