Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Adult-Onset; Diabetes, Autoimmune
• Intervention / Treatment: Drug: Insulin

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
• Enrollment (Actual): 42
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >18 yrs
• Positive for pancreatic autoantibodies

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lund University Hospital
• Collaborators: Landstinget Kronoberg, Sweden

Study record dates

Study Major Dates

• Study Start: February 1, 1995
• Primary Completion (Actual): April 1, 2002
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 23, 2010

Study Record Updates

• Last Update Posted (Estimate): April 23, 2010
• Last Update Submitted That Met QC Criteria: April 22, 2010
• Last Verified: February 1, 1995

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: LundUH-LADA101