Trial | NCT01109927  Report issue

Title

Early Insulin Treatment in Patients With Latent Autoimmune Diabetes
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes (LADA)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    42
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.
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 Started
Feb 28
1995
Primary Completion
Apr 30
2002
Study Completion
May 31
2005
Last Update
Apr 23
2010
Estimate

Drug Insulin

Insulin treatment in accordance to glucose values

Insulin treatment Experimental

Insulin given as soon as possible after diagnosis

Conventional treatment No Intervention

Diet, oral hypoglycemic agents and insulin first when clinically needed

Criteria 

Inclusion Criteria:

>18 yrs
Positive for pancreatic autoantibodies

Exclusion Criteria:

<18 yrs
Significant concomitant diseases
Not able to follow protocol
No Results Posted