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

This study has been completed.
Information provided by:
Tokyo Study Group Identifier:
First received: September 29, 2005
Last updated: September 30, 2005
Last verified: January 2005
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).

Condition Intervention
GAD Ab Positive Clinically Type 2 Diabetic Patients Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Tokyo Study Group:

Primary Outcome Measures:
  • The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).

Estimated Enrollment: 42
Study Start Date: January 1996
Estimated Study Completion Date: January 2005
Detailed 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).

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00232375

University of Yamanashi
Tamaho, Yamanashi, Japan, 409-3898
Sponsors and Collaborators
Tokyo Study Group
Study Director: Tetsuro Kobayashi, Professor Third Department of Internal Medicine, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00232375     History of Changes
Other Study ID Numbers: 13-81
Study First Received: September 29, 2005
Last Updated: September 30, 2005

Keywords provided by Tokyo Study Group:
GAD antibody
Beta cell function

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 22, 2017