title: Randomized, controlled, parallel-group prospective study to investigate the clinical effectiveness of early insulin treatment in patients with latent autoimmune diabetes in adults.
abstract: 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.
authors.affiliation: School of Medicine, Swansea University, Swansea, Wales, UK. s.brophy@swansea.ac.uk
authors.forename: Sinead
authors.initials: S
authors.lastname: Brophy
authors.forename: Helen
authors.initials: H
authors.lastname: Davies
authors.forename: Stephen
authors.initials: S
authors.lastname: Bain
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Stephens
authors.forename: Wei-Yee
authors.initials: WY
authors.lastname: Cheung
authors.forename: Kez
authors.initials: K
authors.lastname: Richards
authors.forename: Kathie
authors.initials: K
authors.lastname: Wareham
authors.forename: Charles
authors.initials: C
authors.lastname: Beaverstock
authors.forename: Janet
authors.initials: J
authors.lastname: Lloyd
authors.forename: Don
authors.initials: D
authors.lastname: Page
authors.forename: Meurig
authors.initials: M
authors.lastname: Williams
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
authors.forename: Rhys
authors.initials: R
authors.lastname: Williams