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

Tokyo Study Group42 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

GAD Ab Positive Clinically Type 2 Diabetic Patients

Interventions

InsulinDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

University of Yamanashi

Tamaho, Yamanashi, Japan

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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