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
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.


CONCLUSIONS
This study seeks the best treatment for early LADA in terms of maintaining glycaemic control and maintaining natural insulin production.


BACKGROUND
ISRCTN63815121.
Brophy
Sinead
S
School of Medicine, Swansea University, Swansea, Wales, UK. s.brophy@swansea.ac.uk
Davies
Helen
H
Bain
Stephen
S
Stephens
Jeffrey W
JW
Cheung
Wei-Yee
WY
Richards
Kez
K
Wareham
Kathie
K
Beaverstock
Charles
C
Lloyd
Janet
J
Page
Don
D
Williams
Meurig
M
Russell
Ian
I
Williams
Rhys
R