Randomized Controlled Trial of Insulin Versus Tablets for Latent Autoimmune Diabetes in Adults (LADA)
Status:
Unknown status
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Background: Latent autoimmune diabetes in adults [LADA] is a type 1 diabetes that is slowly
developing. This means many people are treated as having type 2 diabetes at diagnosis as they
are adults who are not immediately insulin dependent. LADA can be distinguished from type 2
diabetes by antibody tests. Patients who are antibody positive have an autoimmune reaction
which is similar to that of type 1 diabetes and is not found in type 2 diabetes. We would
like to examine the best way of treating LADA in the early phase of the conditions, with
tablets (similar to type 2 diabetes) or with insulin (similar to type 1 diabetes).
Methods/Design: This is an open parallel group prospective randomised trial. Participants
need to have a GAD antibody test results of 101 WHO units or more and a diagnosis of diabetes
not requiring insulin at diagnosis. Participants will need to have been diagnosed within 12
months and not treated with insulin at study entry. They will be randomised to receive either
insulin (NovoMix 30) or tablets (diet treated followed by metformin followed by glitazone
(with or without metformin) followed by insulin). Primary outcome assessment will be for
change in HbA1c and change in fasting C-peptide over 24 months. Secondary outcome measures
will include Quality of life, GAD antibody levels, adverse events, inflammatory markers,
insulin resistance, and markers of the metabolic syndrome.
Discussion: This study seeks the best treatment for early LADA in terms of maintaining
glycaemic control and maintaining natural insulin production.