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

NCT00509925 | Terminated Phase 4 Results

• 2 other identifiers: NN304-17612006-003060-59
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (16)

• Component of Total Energy Expenditure: Resting Energy Expenditure (REE)

  Week 14, week 30

• Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)

  Week 14, week 30

• Component of Total Energy Expenditure: Physical Activity Thermogenesis

  Week 16, week 32

• Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)

  Week 16, week 32

• Body Weight

  Week 16, week 32

Study Arms (2)

Treatment period 1

EXPERIMENTAL

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; Drug: insulin NPH; Drug: insulin aspart

Treatment period 2

EXPERIMENTAL

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; Drug: insulin NPH; Drug: insulin aspart

Interventions

insulin detemir DRUG

Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

Treatment period 1; Treatment period 2

insulin NPH DRUG

Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

Treatment period 1; Treatment period 2

insulin aspart DRUG

Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

Treatment period 1; Treatment period 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Guildford, GU2 7XX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21593292 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Detemir; Insulin, Isophane; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

This open-label study was terminated prematurely due to 2 unplanned interim analyses having been performed. At this point, only 23 out of the planned 30 patients had been randomised into the study.

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 10, 2017
• Results First Posted: August 4, 2010

Record last verified: 2017-01

Locations

GB (1)