Clinical trial NCT00509925: Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes
Official title: A 32-week National, Single-centre, Open-labelled, Randomised, Crossover 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Total Energy Expenditure, Double-labelled Water Method
timeFrame: Weeks 14-16, weeks 30-32
measure: Total Energy Expenditure, Dietary Record Method
timeFrame: Weeks 14-16, weeks 30-32
Secondary outcomes:
measure: Component of Total Energy Expenditure: Resting Energy Expenditure (REE)
timeFrame: Week 14, week 30
measure: Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)
timeFrame: Week 14, week 30
measure: Component of Total Energy Expenditure: Physical Activity Thermogenesis
timeFrame: Week 16, week 32
measure: Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)
timeFrame: Week 16, week 32
measure: Body Weight
timeFrame: Week 16, week 32
measure: Lean Body Mass
timeFrame: Week 16, week 32
measure: Fat Mass
timeFrame: Week 16, week 32
measure: Waist:Hip Ratio
timeFrame: Week 16, week 32
measure: Hormonal Assessment: Adiponectin
timeFrame: Week 14, week 30
measure: Hormonal Assessment: Insulin-like Growth Factor-1
timeFrame: Week 14, week 30
measure: Hormonal Assessment: Resistin
timeFrame: Week 14, week 30
measure: Hormonal Assessment: Leptin
timeFrame: Week 14, week 30
measure: Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Week 16, week 32
measure: Fasting Plasma Glucose
timeFrame: Week 16, week 32
measure: Hypoglycaemic Episodes
timeFrame: Weeks 0-32
measure: Hypoglycaemic Episodes, Diurnal/Nocturnal
timeFrame: Weeks 0-32
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Zachariah S, Sheldon B, Shojaee-Moradie F, Jackson NC, Backhouse K, Johnsen S, Jones RH, Umpleby AM, Russell-Jones DL. Insulin detemir reduces weight gain as a result of reduced food intake in patients with type 1 diabetes. Diabetes Care. 2011 Jul;34(7):1487-91. doi: 10.2337/dc11-0098. Epub 2011 May 18.