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

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

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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, Yamanashi
	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 indexed to this study:

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.

Study ID Numbers:	13-81
First Received:	September 29, 2005
Last Updated:	September 30, 2005
ClinicalTrials.gov Identifier:	NCT00232375
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tokyo Study Group:

SPIDDM

LADA

GAD antibody

Beta cell function

Insulin

Study placed in the following topic categories:

Antibodies

Diabetes Mellitus

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Tokyo Study Group
Information provided by:	Tokyo Study Group
ClinicalTrials.gov Identifier:	NCT00232375