Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

Phase 4

Completed

• Conditions: Diabetes, Autoimmune; Diabetes Mellitus, Adult-Onset
• Interventions: Drug: Insulin

• Registration Number: NCT01109927
• Lead Sponsor: Lund University Hospital

Brief Summary

Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed against the insulin producing beta cells in the pancreas. These patients have a progressive beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes Animal studies in diabetes prone mice have demonstrated potential positive effects of early insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of this study was to investigate the effect of early insulin treatment of LADA patients, in respect to residual beta-cell function and metabolic control, compared to a group who were conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not before it was clinically needed.

Detailed Description

All adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic antibodies. Patients clinically classified as Type 2, not insulin requiring at diagnosis and positive for at least one autoantibody are eligible for inclusion. After randomisation to insulin treatment or diet and/or OHA, the patients are followed up with fasting C-peptide every third month. A glucagon test is performed, and stimulated C-peptide and HbA1c, + clinical data and body weight are recorded at baseline and after 12, 24 and 36 months. The final outcome of the study is C-peptide, and change in C-peptide compared to baseline level, and HbA1c, after 36 months.

Study Timeline

• Status Verified: 1995-02
• Study Start: 1995-02
• Primary Completion: 2002-04
• Study Completion: 2005-05
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-22
• Last Update Submitted: 2010-04-22
• Study First Posted: 2010-04-23
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• >18 yrs
• Positive for pancreatic autoantibodies

Exclusion Criteria

• <18 yrs
• Significant concomitant diseases
• Not able to follow protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Insulin	Diet, oral hypoglycemic agents and insulin first when clinically needed
Insulin treatment	Insulin	Insulin given as soon as possible after diagnosis

Primary Outcome Measures

Name	Time	Method
Glucagon stimulated C-peptide	36 months after entering the study	Glucagon stimulated C-peptide is measured at diagnosis and annually for three years. Basal values will be compared to values obtained after 36 months.