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

This study has been terminated.
(See detailed description)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509925
First Posted: August 1, 2007
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Total Energy Expenditure, Double-labelled Water Method [ Time Frame: Weeks 14-16, weeks 30-32 ]
    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.

  • Total Energy Expenditure, Dietary Record Method [ Time Frame: Weeks 14-16, weeks 30-32 ]
    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.


Secondary Outcome Measures:
  • Component of Total Energy Expenditure: Resting Energy Expenditure (REE) [ Time Frame: Week 14, week 30 ]
    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.

  • Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT) [ Time Frame: Week 14, week 30 ]
    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.

  • Component of Total Energy Expenditure: Physical Activity Thermogenesis [ Time Frame: Week 16, week 32 ]
    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).

  • Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT) [ Time Frame: Week 16, week 32 ]
    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.

  • Body Weight [ Time Frame: Week 16, week 32 ]
    Body weight after each treatment period.

  • Lean Body Mass [ Time Frame: Week 16, week 32 ]
    Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.

  • Fat Mass [ Time Frame: Week 16, week 32 ]
    Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.

  • Waist:Hip Ratio [ Time Frame: Week 16, week 32 ]
    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.

  • Hormonal Assessment: Adiponectin [ Time Frame: Week 14, week 30 ]
    Adiponectin levels after each treatment period.

  • Hormonal Assessment: Insulin-like Growth Factor-1 [ Time Frame: Week 14, week 30 ]
    Insulin-like growth factor-1 (IGF-1) levels after each treatment period.

  • Hormonal Assessment: Resistin [ Time Frame: Week 14, week 30 ]
    Resistin levels after each treatment period.

  • Hormonal Assessment: Leptin [ Time Frame: Week 14, week 30 ]
    Leptin levels after each treatment period.

  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Week 16, week 32 ]
    Glycosylated haemoglobin A1c (HbA1c) after each treatment period.

  • Fasting Plasma Glucose [ Time Frame: Week 16, week 32 ]
    Fasting plasma glucose (FPG) after each treatment period.

  • Hypoglycaemic Episodes [ Time Frame: Weeks 0-32 ]
    Total number of hypoglycaemic episodes experienced in the study.

  • Hypoglycaemic Episodes, Diurnal/Nocturnal [ Time Frame: Weeks 0-32 ]
    Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.


Enrollment: 23
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1
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
Drug: insulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Drug: insulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Drug: insulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Experimental: Treatment period 2
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
Drug: insulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Drug: insulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Drug: insulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509925


Locations
United Kingdom
Novo Nordisk Investigational Site
Guildford, United Kingdom, GU2 7XX
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00509925     History of Changes
Other Study ID Numbers: NN304-1761
2006-003060-59 ( EudraCT Number )
First Submitted: July 31, 2007
First Posted: August 1, 2007
Results First Submitted: April 19, 2010
Results First Posted: August 4, 2010
Last Update Posted: March 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs