Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

• Sponsor: Lund University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01109927
• Collaborator: Landstinget Kronoberg, Sweden (Other)
• Enrollment: 42
• Arms: 2
• Duration (Months): 122.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Feb 1, 1995
• Actual Primary Completion Date: Apr 1, 2002
• Actual Study Completion Date: May 1, 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lund University Hospital
• Landstinget Kronoberg, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01109927
• Other Study ID Numbers: LundUH-LADA101
• First Posted: Apr 23, 2010
• Last Update Posted: Apr 23, 2010
• Last Verified: Feb 1, 1995

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Insulin

Study Results

No Results Posted as of Apr 23, 2010