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Completed

NCT Number: NCT00232375

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

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).

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Key information

Conditions

GAD Ab Positive Clinically Type 2 Diabetic Patients Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Yamanashi

Tamaho, Yamanashi, 409-3898, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Tokyo Study Group

Other

Registry information

Important dates

Study start
1996
Study completion
2005
First posted
Oct 4, 2005
Registry last updated
Oct 4, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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