Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

Diabetes Mellitus, Adult-Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109927
• Other study ID #: LundUH-LADA101
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2010
• Last updated: April 22, 2010
• Start date: February 1995
• Est. completion date: May 2005

Study information

• Verified date: February 1995
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2005
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• >18 yrs

• Positive for pancreatic autoantibodies

Exclusion Criteria:

• <18 yrs

• Significant concomitant diseases

• Not able to follow protocol

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Adult-Onset
• Diabetes Mellitus, Type 2
• Diabetes, Autoimmune

Intervention

Drug:
• Insulin
Insulin treatment in accordance to glucose values

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lund University Hospital	Landstinget Kronoberg, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon stimulated C-peptide	Glucagon stimulated C-peptide is measured at diagnosis and annually for three years. Basal values will be compared to values obtained after 36 months.	36 months after entering the study	No