Early Insulin Treatment in Patients With Latent Autoimmune Diabetes
Primary Purpose
Diabetes, Autoimmune, Diabetes Mellitus, Adult-Onset
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes, Autoimmune
Eligibility Criteria
Inclusion Criteria:
- >18 yrs
- Positive for pancreatic autoantibodies
Exclusion Criteria:
- <18 yrs
- Significant concomitant diseases
- Not able to follow protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Insulin treatment
Conventional treatment
Arm Description
Insulin given as soon as possible after diagnosis
Diet, oral hypoglycemic agents and insulin first when clinically needed
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01109927
First Posted
April 8, 2010
Last Updated
April 22, 2010
Sponsor
Lund University Hospital
Collaborators
Landstinget Kronoberg, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01109927
Brief Title
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes
Official Title
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes (LADA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 1995
Overall Recruitment Status
Completed
Study Start Date
February 1995 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lund University Hospital
Collaborators
Landstinget Kronoberg, Sweden
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Autoimmune, Diabetes Mellitus, Adult-Onset
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin treatment
Arm Type
Experimental
Arm Description
Insulin given as soon as possible after diagnosis
Arm Title
Conventional treatment
Arm Type
No Intervention
Arm Description
Diet, oral hypoglycemic agents and insulin first when clinically needed
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin treatment in accordance to glucose values
Primary Outcome Measure Information:
Title
Glucagon stimulated C-peptide
Description
Glucagon stimulated C-peptide is measured at diagnosis and annually for three years. Basal values will be compared to values obtained after 36 months.
Time Frame
36 months after entering the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 yrs
Positive for pancreatic autoantibodies
Exclusion Criteria:
<18 yrs
Significant concomitant diseases
Not able to follow protocol
12. IPD Sharing Statement
Learn more about this trial
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes
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