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Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

This study has been completed.
Sponsor:
Collaborator:
Landstinget Kronoberg, Sweden
Information provided by:
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01109927
First received: April 8, 2010
Last updated: April 22, 2010
Last verified: February 1995
History of Changes
  Purpose

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 Intervention Phase
Diabetes, Autoimmune
Diabetes Mellitus, Adult-Onset
 Drug: Insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Insulin Treatment in Patients With Latent Autoimmune Diabetes (LADA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • Glucagon stimulated C-peptide [ Time Frame: 36 months after entering the study ] [ Designated as safety issue: No ]
    Glucagon stimulated C-peptide is measured at diagnosis and annually for three years. Basal values will be compared to values obtained after 36 months.


Enrollment: 42
Study Start Date: February 1995
Study Completion Date: May 2005
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 yrs
  • Positive for pancreatic autoantibodies

Exclusion Criteria:

  • <18 yrs
  • Significant concomitant diseases
  • Not able to follow protocol
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mona Landin-Olsson, prof, Dept of Clinical Science, Lund University Hospital, Lund, Sweden, Lund University Hospital, Lund, Sweden
ClinicalTrials.gov Identifier: NCT01109927     History of Changes
Other Study ID Numbers: LundUH-LADA101
Study First Received: April 8, 2010
Last Updated: April 22, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013