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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004662-14-GB

Enrollment

210

Registered

2007-01-16

Start date

2007-02-22

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LADA: Latent autoimmune diabetes in adults MedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: NovoMix 30 Product Name: NovoMix 30 Pharmaceutical Form: Suspension for injection INN or Proposed INN: INSULIN ASPART CAS Number: 116094236 Concentration unit: U/ml unit(s)/millilitre Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026