Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

NCT ID: NCT01109927

Last Updated: 2010-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-02-28
• Study Completion Date: 2005-05-31

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.

Conditions

Diabetes, Autoimmune; Diabetes Mellitus, Adult-Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin treatment

Insulin given as soon as possible after diagnosis

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

Insulin treatment in accordance to glucose values

Conventional treatment

Diet, oral hypoglycemic agents and insulin first when clinically needed

Group Type: NO_INTERVENTION

Insulin

Intervention Type: DRUG

Insulin treatment in accordance to glucose values

Interventions

Insulin

Insulin treatment in accordance to glucose values

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• >18 yrs
• Positive for pancreatic autoantibodies

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Landstinget Kronoberg, Sweden

UNKNOWN

Sponsor Role: collaborator

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lund University Hospital, Lund, Sweden

Other Identifiers

LundUH-LADA101

Identifier Type: -

Identifier Source: org_study_id