Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes

Novo Nordisk

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin NPH; Drug: insulin detemir; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509925

NN304-1761

2006-003060-59 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.

Full description

The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for more than 12 months
• Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal)
• HbA1c (glycosylated haemoglobin A1c) between 7.0 and 11.0%
• Able and willing to maintain consistent physical activity level throughout the entire study period
• Able and willing to maintain consistent eating habits throughout the entire study period

Exclusion criteria

• Proliferative retinopathy that has required acute treatment within the last six months
• Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
• Liver, kidney or heart problems as judged by the Investigator
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
• Known or suspected allergy to trial products or related products
• Receipt of any investigational drug within one month prior to this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Treatment period 1

Experimental group

Description:

Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart

Treatment:

Drug: insulin NPH

Drug: insulin aspart

Drug: insulin detemir

Treatment period 2

Experimental group

Description:

Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart

Treatment:

Drug: insulin NPH

Drug: insulin aspart

Drug: insulin detemir