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

This study has been completed.
Sponsor:
Information provided by:
Tokyo Study Group
ClinicalTrials.gov Identifier:
NCT00232375
First received: September 29, 2005
Last updated: September 30, 2005
Last verified: January 2005
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00232375

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

No publications provided by Tokyo Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00232375     History of Changes
Other Study ID Numbers: 13-81
Study First Received: September 29, 2005
Last Updated: September 30, 2005
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 24, 2014