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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232375
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : October 4, 2005
Information provided by:
Tokyo Study Group

Brief 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).

Condition or disease Intervention/treatment
GAD Ab Positive Clinically Type 2 Diabetic Patients Drug: Insulin

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 1996
Estimated Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00232375     History of Changes
Other Study ID Numbers: 13-81
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: October 4, 2005
Last Verified: January 2005

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs