Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109927
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : April 23, 2010
Landstinget Kronoberg, Sweden
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes, Autoimmune Diabetes Mellitus, Adult-Onset Drug: Insulin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Insulin Treatment in Patients With Latent Autoimmune Diabetes (LADA)
Study Start Date : February 1995
Actual Primary Completion Date : April 2002
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Insulin treatment
Insulin given as soon as possible after diagnosis
Drug: Insulin
Insulin treatment in accordance to glucose values

No Intervention: Conventional treatment
Diet, oral hypoglycemic agents and insulin first when clinically needed
Drug: Insulin
Insulin treatment in accordance to glucose values

Primary Outcome Measures :
  1. Glucagon stimulated C-peptide [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >18 yrs
  • Positive for pancreatic autoantibodies

Exclusion Criteria:

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

Responsible Party: Mona Landin-Olsson, prof, Dept of Clinical Science, Lund University Hospital, Lund, Sweden, Lund University Hospital, Lund, Sweden Identifier: NCT01109927     History of Changes
Other Study ID Numbers: LundUH-LADA101
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: February 1995

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs