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

Diabetes Clinical Trial

Official title:

Effect of Insulin Detemir Compared to Insulin NPH Combined With Insulin Aspart on Energy Expenditure in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00509925
• Other study ID #: NN304-1761
• Secondary ID: 2006-003060-59
• Status: Terminated
• Phase: Phase 4
• First received: July 31, 2007
• Last updated: June 26, 2012
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2012
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
• insulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
• insulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Energy Expenditure, Double-labelled Water Method	Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.	Weeks 14-16, weeks 30-32	No
Primary	Total Energy Expenditure, Dietary Record Method	The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.	Weeks 14-16, weeks 30-32	No
Secondary	Component of Total Energy Expenditure: Resting Energy Expenditure (REE)	Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation.	Week 14, week 30	No
Secondary	Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)	Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake.	Week 14, week 30	No
Secondary	Component of Total Energy Expenditure: Physical Activity Thermogenesis	Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32).	Week 16, week 32	No
Secondary	Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)	Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT.	Week 16, week 32	No
Secondary	Body Weight	Body weight after each treatment period.	Week 16, week 32	No
Secondary	Lean Body Mass	Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.	Week 16, week 32	No
Secondary	Fat Mass	Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.	Week 16, week 32	No
Secondary	Waist:Hip Ratio	At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100.	Week 16, week 32	No
Secondary	Hormonal Assessment: Adiponectin	Adiponectin levels after each treatment period.	Week 14, week 30	No
Secondary	Hormonal Assessment: Insulin-like Growth Factor-1	Insulin-like growth factor-1 (IGF-1) levels after each treatment period.	Week 14, week 30	No
Secondary	Hormonal Assessment: Resistin	Resistin levels after each treatment period.	Week 14, week 30	No
Secondary	Hormonal Assessment: Leptin	Leptin levels after each treatment period.	Week 14, week 30	No
Secondary	Glycosylated Haemoglobin A1c (HbA1c)	Glycosylated haemoglobin A1c (HbA1c) after each treatment period.	Week 16, week 32	No
Secondary	Fasting Plasma Glucose	Fasting plasma glucose (FPG) after each treatment period.	Week 16, week 32	No
Secondary	Hypoglycaemic Episodes	Total number of hypoglycaemic episodes experienced in the study.	Weeks 0-32	Yes
Secondary	Hypoglycaemic Episodes, Diurnal/Nocturnal	Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.	Weeks 0-32	Yes

External Links

•   Clinical Trials at Novo Nordisk