Randomized Controlled Trial of Insulin Versus Tablets for Latent Autoimmune Diabetes in Adults (LADA) (LIT)
Recruitment status was: Recruiting
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.
Latent Autoimmune Diabetes in Adults LADA
Drug: NovoMix 30
Drug: Tablet treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in fasting serum C-peptide level over 24 months and (2) change in HbA1c level over 24 months in patients with LADA. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Hypoglycaemic events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Insulin: NovoMix 30. Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal.
Drug: NovoMix 30
Insulin arm: Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal. Dose will be adjusted in increments of 2-6U depending on fasting glucose level When total dose equals 16 U patient will be started on 4 units with breakfast and continue with 16 units with evening meal. Breakfast and/or evening meal dose will be adjusted where necessary at increments of 2-6 U depending on fasting and/or pre-evening meal glucose level. Patient needs to keep a daily diary of insulin doses taken.
Active Comparator: Tablet
Patients will progress from lifestyle modification to metformin, to metformin with Rosiglitazone and finally insulin depending on HbA1c levels.
Drug: Tablet treatment
Step 1: Lifestyle modification. If HbA1c at 7%+ or if on metformin/sulphonylurea go to step 2. Step 2: Glucophage. If HbA1c of 7%-7.5% give 500mg x 1 per day. If HbA1c 7.6%-8.0%, week 1 - 500mg x 1 day and then 500mg x 2 day. If HbA1c 8.0%+ then 500mg x 3 per day (Titrated). If HbA1c remains 7%+ give additional tablet until 2gms per day then progress to Step 3. Step 3: Rosiglitazone. HbA1c of 7%+ give 4 mg per day. If HbA1c remains 7%+ titrate to maximal dose 4 mg twice daily +/-Metformin. If HbA1c remains 7% + for an 3 months move to step 4. Before initiation of Rosiglitazone repeat medical history with special emphasis on cardiovascular disease, if patient has a history of CVD move to Step 4 (insulin). Any adverse events suggestive of heart disease move to step 4. Step 4: Insulin (oral agents will be stopped). Initiation of insulin will the same as for the insulin arm and will follow the protocol detailed in the Insulin arm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776607
|Cardiff, Wales, United Kingdom, CF64 2XX|
|Clinical Research Unit|
|Swansea, Wales, United Kingdom, SA6 6NL|
|Principal Investigator:||Sinead Brophy||Swansea University|
|Study Director:||Stephen Bain||Swansea University|