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

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Medicines

Drug Information available for: Insulin human

U.S. FDA Resources

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

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):

Maruyama T, Tanaka S, Shimada A, Funae O, Kasuga A, Kanatsuka A, Takei I, Yamada S, Harii N, Shimura H, Kobayashi T. Insulin intervention in slowly progressive insulin-dependent (type 1) diabetes mellitus. J Clin Endocrinol Metab. 2008 Jun;93(6):2115-21. Epub 2008 Apr 8.

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

Additional relevant MeSH terms:

Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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