Study protocol

Randomized, controlled, parallel-group prospective study to investigate the clinical effectiveness of early insulin treatment in patients with latent autoimmune diabetes in adults

Sinead Brophy¹ , Helen Davies¹ , Stephen Bain¹ , Jeffrey W Stephens¹ , Wei-yee Cheung¹ , Kez Richards² , Kathie Wareham² , Charles Beaverstock³ , Janet Lloyd⁴ , Don Page⁴ , Meurig Williams⁵ , Ian Russell⁶ and Rhys Williams¹

¹  School of Medicine, Swansea University, Swansea, Wales, UK

²  Clinical Research Unit, Swansea NHS Trust. Swansea, Wales, UK

³  Diabetes Unit, Neath Port Talbot Hospital, Neath Port Talbot, Wales, UK

⁴  Diabetes UK Cymru, Argyle House Castlebridge, Cowbridge, Cardiff, CF11 9AB, UK

⁵  Diabetes Centre, Prince Philip Hospital, Llanelli, Carmarthenshire, Wales, UK

⁶  Institute for Medical and Social Care Research, University of Wales, Bangor, Wales, UK

author email corresponding author email

BMC Endocrine Disorders 2008, 8:8doi:10.1186/1472-6823-8-8

Published:	24 July 2008

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/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.

Trial registration

ISRCTN63815121