We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232375
First Posted: October 4, 2005
Last Update Posted: October 4, 2005
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.
Information provided by:
Tokyo Study Group
  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
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 29, 2005
First Posted: October 4, 2005
Last Update Posted: October 4, 2005
Last Verified: January 2005

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

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs