Randomized, controlled, parallel-group study to investigate the clinical effictiveness of early insulin treatment in patients with latent autoimmune diabetes in adults [LADA] - LIT

Phase 1

Conditions: ADA: Latent autoimmune diabetes in adults
MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

Registration Number: EUCTR2006-004662-14-GB

Lead Sponsor: Swansea NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

Inclusion Criteria

1. Diagnosed with diabetes according to WHO classificaiton
2. Positive for GAD antibody of 101 units or more on two separate occasions
3. Age 18+
4. Not on insulin within 1 month of diagnosis
5. Written informed consent
6. Ability to comply with all the study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Acute infection
2. Malignancy
3. Severe renal failure or GFR<30
4. Severe blood loss within 2 months of starting trial
5. Proliferative retinopathy
6. Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Change in fasting serum C-peptide level at 24 months in LADA patients treated with insulin (standard care for type 1 diabetes) compared to those treated with tablets (standard care for type 2 diabetes);Secondary Objective: Change in HbA1c, fasting glucose, GAD antibody, quality of life, insulin sensitivity, adverse events and weight/blood pressure/cholesterol in LADA patients given insulin (standard care for type 1 diabetes) and those given tablets (standard care for type 2 diabetes).;Primary end point(s): C peptide level at 24 months in insulin treated compared to tablet treated patients

Secondary Outcome Measures