Latent Autoimmune Diabetes in Adults LADA Clinical Trial
Official title:
Randomized, Controlled, Parallel-Group Prospective Study to Investigate the Clinical Effectiveness of Early Insulin Treatment in Patients With Latent Autoimmune Diabetes in Adults
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment