Is "Beta Cell Rest" by Insulin Treatment Beneficial Compared to State-of-the Art Enhancers of Insulin Secretion in Preserving Beta Cell Function in Subjects With Latent Autoimmune Diabetes of the Adult (LADA)?
Latent autoimmune diabetes of the adult (LADA) is usually defined as a form of diabetes
where the onset of diabetes takes place approximately after 30 years of age, where there is
presence of beta-cell directed antibodies (mostly anti-GAD) and where there is no clinical
need for insulin treatment during the first 6 months after the diagnosis of diabetes.
The aetiology and treatment of LADA patients is much less elucidated than is the case for
type 1 diabetes (DM1) and type 2 diabetes (DM2). LADA constitutes about 10 % of the total
diabetic population in many countries. LADA is therefore more common than insulin-requiring
LADA patients lose beta-cell function faster than patients with DM2. Residual beta-cell
function in DM1 is coupled to better metabolic control with lesser degree of hyperglycemia,
lesser frequency of hypoglycaemic events and lesser diabetic complications.
To retain beta-cell function in LADA patients is thus highly desirable.
There are several strategies to retain beta cell function. One therapeutic strategy is to
induce some degree of "beta cell rest" by treatment with exogenous insulin. Several
observations indicate that such a strategy can have beneficial effects.
This is a Scandinavian multicenter non-blinded clinical trial with 78 participants with
newly diagnosed LADA. Participants will be randomized to either insulin- or per oral
antidiabetic treatment. Participants will be followed up for 2 years after inclusion. Beta
cell function and glycemic control will be monitored.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
insulin secretion measured by fasting and glucagon-stimulated C-peptide
Valdemar Grill, M.D.
Department of Cancer Research and Molecular Medicine
Norway:National Committee for Medical and Health Research Ethics