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Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00537303
First received: September 28, 2007
Last updated: January 30, 2017
Last verified: January 2017
  Purpose

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 36 ]
    Analysed for the full analysis set.

  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 36 ]
    Measured for the Per Protocol analysis set.


Secondary Outcome Measures:
  • Hypoglycaemic Episodes [ Time Frame: Weeks 0-36 ]
    Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  • Biochemistry: Serum Alanine Aminotransferase [ Time Frame: week 36 ]
    Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.

  • Haematology: Haemoglobin Measured in Blood [ Time Frame: week 36 ]
    Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.

  • Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide [ Time Frame: week 36 ]
    High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.


Enrollment: 296
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advanced
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Drug: insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
Drug: insulin aspart
Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
Active Comparator: Basic
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Drug: insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
Drug: insulin aspart
Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus for more than 6 months
  • HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
  • BMI (Body Mass Index) less than 40 kg/m2
  • Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
  • Treatment with one to 3 OADs

Exclusion Criteria:

  • Known or suspected allergy to trial products or related products
  • Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
  • Previous participation in any trial including this for the last 6 months
  • Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537303

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Mission Viejo, California, United States, 92691
United States, Florida
Novo Nordisk Investigational Site
Miami, Florida, United States, 33136
United States, Georgia
Novo Nordisk Investigational Site
Athens, Georgia, United States, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
United States, Iowa
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314-3027
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
United States, Ohio
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
Novo Nordisk Investigational Site
Kettering, Ohio, United States, 45429
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23294
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Denmark
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Finland
Novo Nordisk Investigational Site
Espoo, Finland, FI-02650
Novo Nordisk Investigational Site
Oulu, Finland, FI-90100
Novo Nordisk Investigational Site
Oulu, Finland, FI-90220
Novo Nordisk Investigational Site
Tampere, Finland, 33100
Novo Nordisk Investigational Site
Vaasa, Finland, FIN-61500
Novo Nordisk Investigational Site
Vantaa, Finland, FI-01620
Former Serbia and Montenegro
Novo Nordisk Investigational Site
Belgrade, Former Serbia and Montenegro, 11000
Novo Nordisk Investigational Site
Nis, Former Serbia and Montenegro, 18000
France
Novo Nordisk Investigational Site
Le Creusot, France, 71200
Novo Nordisk Investigational Site
Nanterre, France, 92014
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
Pointe à Pitre, France, 97159
Novo Nordisk Investigational Site
Venissieux, France, 69200
Netherlands
Novo Nordisk Investigational Site
Den Bosch, Netherlands, 5216 GC
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5631 BM
Novo Nordisk Investigational Site
Etten-Leur, Netherlands, 4872 LP
Novo Nordisk Investigational Site
Hulst, Netherlands, 4561 NV
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3563 AZ
Novo Nordisk Investigational Site
Woerden, Netherlands, 3443 GG
Norway
Novo Nordisk Investigational Site
Jessheim, Norway, 2050
Novo Nordisk Investigational Site
Oslo, Norway, 0160
Novo Nordisk Investigational Site
Sarpsborg, Norway, 1702
Novo Nordisk Investigational Site
Stavanger, Norway, 4011
Novo Nordisk Investigational Site
Tromsø, Norway, 9038
Novo Nordisk Investigational Site
Tønsberg, Norway, 3116
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site
Moscow, Russian Federation, 123448
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127644
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1818
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1829
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0001
Spain
Novo Nordisk Investigational Site
Cáceres, Spain, 10004
Novo Nordisk Investigational Site
Inca, Spain, 07300
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Novo Nordisk Investigational Site
Mostoles - Madrid -, Spain, 28935
Novo Nordisk Investigational Site
Málaga, Spain, 29010
Novo Nordisk Investigational Site
Mérida, Spain, 06800
Novo Nordisk Investigational Site
Santiago de Compostela, Spain, 15706
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 417 17
Novo Nordisk Investigational Site
Mölndal, Sweden, 431 80
Novo Nordisk Investigational Site
Ängelholm, Sweden, 262 91
United Kingdom
Novo Nordisk Investigational Site
Aberdeen, United Kingdom, AB25 1LD
Novo Nordisk Investigational Site
Coventry, United Kingdom, CV2 2DX
Novo Nordisk Investigational Site
Livingstone, United Kingdom, EH54 6PP
Novo Nordisk Investigational Site
Llanelli, United Kingdom, SA14 8QF
Novo Nordisk Investigational Site
Llantrisant, United Kingdom, CF72 8XR
Novo Nordisk Investigational Site
Reading, United Kingdom, RG7 3SQ
Novo Nordisk Investigational Site
Rugby, United Kingdom, CV22 5PX
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: NCT00537303     History of Changes
Other Study ID Numbers: NN304-1833
2007-000123-18 ( EudraCT Number )
Study First Received: September 28, 2007
Results First Received: July 16, 2010
Last Updated: January 30, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Detemir
Hypoglycemic Agents
Insulin Aspart
Insulin, Long-Acting
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017