---
title: Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes
nct_id: NCT00232375
overall_status: COMPLETED
phase: NA
sponsor: Tokyo Study Group
study_type: INTERVENTIONAL
primary_condition: GAD Ab Positive Clinically Type 2 Diabetic Patients
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00232375.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00232375"
ct_last_update_post_date: 2005-10-04
last_seen_at: "2026-05-12T06:28:22.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes

**NCT ID:** [NCT00232375](https://clinicaltrials.gov/study/NCT00232375)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** Tokyo Study Group
- **Conditions:** GAD Ab Positive Clinically Type 2 Diabetic Patients
- **Start Date:** 1996-01
- **Completion Date:** 2005-01
- **CT.gov Last Update:** 2005-10-04

## Brief Summary

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).

## 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

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Interventions

- **Insulin** (DRUG)

## Primary Outcomes

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

## Locations (1)

- University of Yamanashi, Tamaho, Yamanashi, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of yamanashi|tamaho|yamanashi|japan` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00232375*  
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