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A 32 week, national, single-centre, open-labelled, randomised, cross-over trial comparing energy expenditure with insulin detemir versus NPH insulin using a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes

A 32 week, national, single-centre, open-labelled, randomised, cross-over trial comparing energy expenditure with insulin detemir versus NPH insulin using a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003060-59-GB
Enrollment
Unknown
Registered
2006-09-29
Start date
2007-03-16
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Type 1 diabetes mellitus MedDRA version: 8.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus

Interventions

Trade Name: Levemir Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin detemir Current Sponsor code: NN304 Concentration unit: IU/ml international unit(s)/millilitre Concentratio

Sponsors

Novo Nordisk Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Informed consent 2. Type 1 diabetes 3. Duration of type 1 diabetes >/= 12 months 4. Current treatment: basal bolus insulin regimen >/= 3 months 5. Age >/= 18 years 6. BMI /= 7.0% and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Previous participation in this trial (defined as randomised) 2. Anticipated change in concomitant medication known to interfere with glucose metabolism 3. Proliferative retinopathy that has required acute treatment within the last 6 months 4. Recurrent major hypoglycaemia or hypoglycaemic unawareness 5. Impaired hepatic or renal function 6. Cardiac problems 7. Uncontrolled hypertension (treated or untreated) 8. Mental incapacity, unwillingness or language barrier precluding understanding or co-operation 9. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contarceptive measures 10. Known or suspected allergy to trial products or related products 11. Receipt of any investigational drug within one month prior to the trial 12. Any other condition that the investigator feels would interfere with trial participation or evaluation of results

Design outcomes

Primary

MeasureTime frame
Main Objective: To measure energy expenditure before and after 16 weeks of treatment with insulin detemir in combination with insulin aspart as mealtime insulin, in comparison with energy expenditure before and after 16 weeks of treatment with NPH insulin.;Secondary Objective: To compare the two treatments in terms of outcome after each treatment period with respect to: - Nutritional and food intake - Body measurements - Insulin requirements - CGMS glucose profiles (optional for patients) - Hormonal assessment - Metabolic control;Primary end point(s): Energy expenditure after each 16 week treatment period—

Countries

United Kingdom

Outcome results

None listed

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